Clinical Trial Results:
Impact of stomach motility on the gastrointestinal behavior of fosamprenavir in healthy volunteers
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Summary
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EudraCT number |
2016-005043-16 |
Trial protocol |
BE |
Global end of trial date |
29 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Apr 2023
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First version publication date |
01 Apr 2023
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Other versions |
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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 |
DDD17FPV
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Clinical Trial Center UZ Leuven: S59932 | ||
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Sponsors
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Sponsor organisation name |
UZLeuven
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Sponsor organisation address |
Herestraat, Leuven, Belgium, 3000
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Public contact |
Patrick Augustijns, KU Leuven, +32 16330301, patrick.augustijns@kuleuven.be
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Scientific contact |
Patrick Augustijns, KU Leuven, +32 16330301, patrick.augustijns@kuleuven.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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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 |
05 Jun 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 |
29 Jan 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 |
To evaluate the impact of gastric motility on the gastrointestinal behavior of a fosamprenavir tablet in healthy volunteers and its implications for systemic drug exposure
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Protection of trial subjects |
xylocaine spray/gel during positioning and removal of nasogastric catheter
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Sep 2018
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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 |
Belgium: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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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) |
7
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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 |
Only Healthy volunteers were recruited. Main exclusion criteria: (potential) pregnancy history of gastrointestinal pathology and/or illness at the time of the study. | |||||||||
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Pre-assignment
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Screening details |
Healthy volunteers | |||||||||
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Period 1
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Period 1 title |
overall study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Telzir in MMC phase 1 | |||||||||
Arm description |
Oral administration of one tablet of Telzir (700 mg fosamprenavir calcium) with 240 mL of tap water during MMC phase I (i.e. absence of contractions). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
fosamprenavir calcium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Oral administration of one tablet of Telzir (700 mg fosamprenavir calcium) with 240 mL of tap water during MMC phase I (i.e. absence of contractions).
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Arm title
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Telzir in MMC phase 2 | |||||||||
Arm description |
Oral administration of one tablet of Telzir (700 mg fosamprenavir calcium) with 240 mL of tap water during MMC phase II (i.e. period of gastric contractions). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
fosamprenavir calcium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Oral administration of one tablet of Telzir (700 mg fosamprenavir calcium) with 240 mL of tap water during MMC phase II (i.e. period of gastric contractions).
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Baseline characteristics reporting groups
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Reporting group title |
overall study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Telzir in MMC phase 1
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Reporting group description |
Oral administration of one tablet of Telzir (700 mg fosamprenavir calcium) with 240 mL of tap water during MMC phase I (i.e. absence of contractions). | ||
Reporting group title |
Telzir in MMC phase 2
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Reporting group description |
Oral administration of one tablet of Telzir (700 mg fosamprenavir calcium) with 240 mL of tap water during MMC phase II (i.e. period of gastric contractions). | ||
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End point title |
not applicable [1] | |||||||||
End point description |
Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable
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End point type |
Primary
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End point timeframe |
not applicable
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable |
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| Notes [2] - data from 2 HV were excluded (problem with catheter + problem with difference between MMC1 and MMC2) [3] - In one participant, the different MMC phases could not be clearly distinguished from each other |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no adverse events during the trial |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/31682976 |
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