Clinical Trial Results:
A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye-free Mini-tablet (Solid and Suspension) Compared to a Single Dose of Azo Dye-containing Tablet in Healthy Adult Subjects
Summary
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EudraCT number |
2018-002924-18 |
Trial protocol |
DE |
Global end of trial date |
14 Oct 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Oct 2020
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First version publication date |
09 Oct 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
1517-CL-1001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03960489 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Astellas Pharma Global Development, Inc. (APGD)
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Sponsor organisation address |
1 Astellas Way, Northbrook, IL, United States, 60062
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Public contact |
Clinical Trial Disclosure, Astellas Pharma Global Development, Inc. (APGD), 31 71 5455 050, astellas.resultsdisclosure@astellas.com
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Scientific contact |
Clinical Trial Disclosure, Astellas Pharma Global Development, Inc. (APGD), 31 71 5455 050, astellas.resultsdisclosure@astellas.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001557-PIP01-13 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Oct 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Oct 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study was to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.
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Protection of trial subjects |
This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jul 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were enrolled in one site in Germany. | |||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants were randomized in 1:1:1:1 ratio to 1 of 4 treatment sequence in the study. Each participant participated in 4 treatment periods separated by a washout of at least 7 days. | |||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment Period 1 (6 days)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Arm title
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Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Arm title
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Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Arm title
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Treatment Sequence 4 (DCBA) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Period 2
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Period 2 title |
Washout Period 1 (7 days)
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Is this the baseline period? |
No | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 4 (DCBA) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 3
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Period 3 title |
Treatment Period 2 (6 days)
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Is this the baseline period? |
No | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Arm title
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Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Arm title
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Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Arm title
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Treatment Sequence 4 (DCBA) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
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Period 4
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Period 4 title |
Washout Period 2 (7 days)
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Is this the baseline period? |
No | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 4 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 5
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Period 5 title |
Treatment Period 3 (6 days)
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Is this the baseline period? |
No | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 4 (DCBA) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
|
||||||||||||||||||||||||||
Period 6
|
||||||||||||||||||||||||||
Period 6 title |
Washout Period 3 (7 days)
|
|||||||||||||||||||||||||
Is this the baseline period? |
No | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||||||||||||
Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
|
||||||||||||||||||||||||||
Are arms mutually exclusive |
No
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 4 (DCBA) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||||||||||||
|
||||||||||||||||||||||||||
Period 7
|
||||||||||||||||||||||||||
Period 7 title |
Treatment Period 4 (6 days)
|
|||||||||||||||||||||||||
Is this the baseline period? |
No | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||||||||||||
Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
|
||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 1 (ABCD) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 2 (BDAC) | |||||||||||||||||||||||||
Arm description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 3 (CADB) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
Arm title
|
Treatment Sequence 4 (DCBA) | |||||||||||||||||||||||||
Arm description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Roxadustat 100 mg azo dye free tablet/mini tablet suspension/solid mini tablet/dye containing tablet
|
|||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||
Pharmaceutical forms |
Oral suspension, Tablet
|
|||||||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||||||
Dosage and administration details |
Participants received 100 mg roxadustat pediatric azo dye-free tablet or dye free mini tablet suspension or dye free solid mini tablet or dye containing tablet as per the dosing sequence.
|
|||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 1 (ABCD)
|
||
Reporting group description |
Participants received single dose of 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 3 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 2 (BDAC)
|
||
Reporting group description |
Particpants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 1 followed by single dose of 100 mg of roxadustat azo dye-containing tablet (D), orally on day 1 in period 2 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 3 (CADB)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 1 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 2 followed by 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 3 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Reporting group title |
Treatment Sequence 4 (DCBA)
|
||
Reporting group description |
Participants received single dose of 100 mg roxadustat azo dye-containing tablet (D), orally on day 1 in period 1 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet solid (C), orally on day 1 in period 2 followed by 100 mg roxadustat pediatric azo dye-free mini-tablet suspension (B), orally on day 1 in period 3 followed by 100 mg of roxadustat pediatric azo dye-free tablet (A), orally on day 1 in period 4. Each period was of 6 days. A washout period of 7 days was included between each period. | ||
Subject analysis set title |
Roxadustat azo dye-free tablet 100 mg
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received 100 mg roxadustat pediatric azo dye-free tablet, orally on day 1 as per the dosing sequence in each period.
|
||
Subject analysis set title |
Roxadustat azo dye-free mini tablet suspension 100 mg
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension, orally on day 1 as per the dosing sequence in each period.
|
||
Subject analysis set title |
Roxadustat azo dye-free mini tablet 100 mg
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received 100 mg roxadustat pediatric azo dye-free solid mini-tablet, orally on day 1 as per the dosing sequence in each period.
|
||
Subject analysis set title |
Roxadustat azo dye-containing tablet 100 mg
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received 100 mg roxadustat azo dye-containing tablet, orally on day 1 as per the dosing sequence in each period.
|
|
|||||||||||||||||||||
End point title |
Area Under the Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf) for Roxadustat | ||||||||||||||||||||
End point description |
AUCinf was defined as area under the plasma concentration versus time curve from time of dosing (pre-dose) to extrapolated infinite time (0-inf). The analysis population was pharamcokinetic analysis set (PKAS) which included all randomized participants who received at least 1 dose of study drug and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter and who had available data.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 23, (and not 45; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free tablet 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
98.07
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
93.81 | ||||||||||||||||||||
upper limit |
102.52 | ||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 23, (and not 46; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free mini tablet suspension 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
103.13
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
98.73 | ||||||||||||||||||||
upper limit |
107.73 | ||||||||||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 23, (and not 45; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free mini tablet 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
98.08
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
93.82 | ||||||||||||||||||||
upper limit |
102.53 |
|
|||||||||||||||||||||
End point title |
Area Under the Concentration-Time Curve From the Time of Dosing to Last Measurable Concentration (AUClast) for Roxadustat | ||||||||||||||||||||
End point description |
AUClast was defined as area under the plasma concentration time-curve from time of dosing to the last measured concentration. The analysis population consisted of PKAS and who had available data.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 23, (and not 45; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free tablet 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
98.15
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
93.85 | ||||||||||||||||||||
upper limit |
102.63 | ||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 23, (and not 46; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free mini tablet suspension 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
103.22
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
98.78 | ||||||||||||||||||||
upper limit |
107.85 | ||||||||||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 23, (and not 45; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free mini tablet 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
98.08
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
93.79 | ||||||||||||||||||||
upper limit |
102.57 |
|
|||||||||||||||||||||
End point title |
Pharmacokinetics (PK) of Maximum Observed Concentration of Roxadustat | ||||||||||||||||||||
End point description |
Maximum observed concentration (Cmax) was reported. The analysis population consisted of PKAS and with available data.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 24, (and not 46; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free tablet 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
99.62
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
91.69 | ||||||||||||||||||||
upper limit |
108.24 | ||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 24, (and not 47; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free mini tablet suspension 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
47
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
98.84
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
91.09 | ||||||||||||||||||||
upper limit |
107.25 | ||||||||||||||||||||
Statistical analysis title |
Statistical Analysis 3 | ||||||||||||||||||||
Statistical analysis description |
Assessment based on an analysis of variance performed on natural log-transformed parameter with sequence, period and formulation as fixed effects and participants as a random effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages. The actual number of participants analyzed is 24, (and not 46; this is a system limitation).
|
||||||||||||||||||||
Comparison groups |
Roxadustat azo dye-free mini tablet 100 mg v Roxadustat azo dye-containing tablet 100 mg
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
Method |
|||||||||||||||||||||
Parameter type |
Geometric LS Mean Ratio | ||||||||||||||||||||
Point estimate |
94.45
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
90% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
86.93 | ||||||||||||||||||||
upper limit |
102.62 |
|
|||||||||||||||||||||
End point title |
Percentage of the Area Under the Concentration-Time Curve From the Time of Dosing to Time infinity due to Extrapolation From the Last Measurable Concentration to Time Infinity (AUCinf[%extrap]) for Roxadustat | ||||||||||||||||||||
End point description |
AUC%extrap was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The analysis population consisted of PKAS and with available data.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Apparent Total Systemic Clearance of Roxadustat After Extravascular Dosing (CL/F) | ||||||||||||||||||||
End point description |
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. The analysis population consisted of PKAS and with available data.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
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No statistical analyses for this end point |
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End point title |
Terminal Elimination Half-life (t1/2) of Roxadustat | ||||||||||||||||||||
End point description |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. The analysis population consisted of PKAS and with available data.
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End point type |
Secondary
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End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
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No statistical analyses for this end point |
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End point title |
Time to Reach Maximum Concentration (tmax) of Roxadustat | ||||||||||||||||||||
End point description |
Time to reach maximum concentration of roxadustat following drug administration (tmax) was reported. The analysis population consisted of PKAS and with available data.
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End point type |
Secondary
|
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End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
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No statistical analyses for this end point |
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End point title |
Time Prior to the Time Corresponding to the First Measurable (nonzero) Concentration (tlag) of Roxadustat | ||||||||||||||||||||
End point description |
Tlag was defined as the time prior to the time corresponding to the first measurable concentration. The analysis population consisted of PKAS and with available data.
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End point type |
Secondary
|
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End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
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No statistical analyses for this end point |
|
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End point title |
Apparent Volume of Distribution During the Terminal Elimination Phase After Extravascular Dosing (Vz/F) of Roxadustat | ||||||||||||||||||||
End point description |
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. The analysis population consisted of PKAS and with available data.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Predose (0 hour), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose on day 1
|
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No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) | |||||||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a participant who was given the study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment. An AE could therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event was defined as an adverse event with onset at any time from dosing until the last scheduled procedure. Safety analysis set included all randomized participants who received at least 1 dose of study drug.
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End point type |
Secondary
|
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End point timeframe |
From first dose of study drug up to end of study visit (up to 54 days)
|
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|
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No statistical analyses for this end point |
|
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Adverse events information
|
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Timeframe for reporting adverse events |
From first dose of study drug up to end of study visit (up to 54 days)
|
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Adverse event reporting additional description |
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
|
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Reporting groups
|
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Reporting group title |
Roxadustat azo dye-free tablet 100 mg
|
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Reporting group description |
Participants received 100 mg roxadustat pediatric azo dye-free tablet, orally on day 1 in each period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Roxadustat azo dye-free mini tablet suspension 100 mg
|
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Reporting group description |
Participants received 100 mg roxadustat pediatric azo dye-free mini-tablet suspension, orally on day 1 in each period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Roxadustat azo dye-free mini tablet 100 mg
|
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Reporting group description |
Participants received 100 mg roxadustat pediatric azo dye-free solid mini-tablet, orally on day 1 in each period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Roxadustat azo dye-containing tablet 100 mg
|
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Reporting group description |
Participants received 100 mg roxadustat azo dye-containing tablet, orally on day 1 in each period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
20 Jun 2019 |
The changes included:
1.Addition of text to clarify that informed consent was to be obtained and signed by the participant prior to any study-related procedures at screening and that the participant must have met all the inclusion and none of the exclusion criteria on day -1.
2.Update of the alcohol exclusionary alcohol consumption limit for males and females in the exclusion criteria from a higher allowed weekly limit to a lower allowed daily limit.
3.Addition of exclusion criterion to exclude participants with abnormal renal function, indicated by creatinine above the upper limit of normal or chronic kidney disease (CKD) epidemiology collaboration based on the estimated glomerular filtration rate of < 90 milliliter/minute (mL/min) on day -1.
4. Addition of pregnancy to the reasons why a participant must have discontinued from study treatment.
5. Update to text to state that the premature termination of the study for reasonable cause was not optional. Addition of reasons that was to result in premature discontinuation of the study and of text to state that the whole study may have been terminated or suspended upon the request of regulatory authorities. In addition, text was added to state that regulatory authorities and the independent ethics committee (IEC) was to be informed about the discontinuation of the study. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |