Clinical Trial Results:
Gastrointestinal behavior of abirateronacetaat in healthy volunteers
Summary
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EudraCT number |
2013-005594-51 |
Trial protocol |
BE |
Global end of trial date |
24 Aug 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Oct 2023
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First version publication date |
12 Oct 2023
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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 |
FTB14-ABA01
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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 Trail Center: s00000 | ||
Sponsors
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Sponsor organisation name |
KU Leuven Drug delivery & Disposition
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Drug Delivery and Disposition, KU Leuven, 32 16379505, patick.augustijns@kuleuven.be
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Scientific contact |
Drug Delivery and Disposition, KU Leuven, 32 16379505, patick.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 |
15 Oct 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Aug 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Aug 2015
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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 gastrointestinal behavior and absorption of abirateronacetate.
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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 |
07 Jul 2014
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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 |
healthy males | |||||||||
Pre-assignment
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Screening details |
healthy males | |||||||||
Period 1
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Period 1 title |
intraluminal behavior abiraterone (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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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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only fasted state | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
abiraterone acetate (zytiga)
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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 |
After a fasting period of 12 h a tablet of 250 mg abiraterone acetate (ZYTIGA, Janssen-Cilag International NV) was administered orally with 250 ml of water to the volunteers.
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Arm title
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fasted and fed state | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
abiraterone acetate (zytiga)
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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 |
After a fasting period of 12 h a tablet of 250 mg abiraterone acetate (ZYTIGA, Janssen-Cilag International NV) was administered orally with 250 ml of water to the volunteers.
For the experiments in the fed state, 400 mL of Ensure Plus Vanilla® was administered 20 min before intake of the abiraterone acetate tablet with 250-mL water. Ensure Plus Vanilla® was used to simulate a standard meal.
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Baseline characteristics reporting groups
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Reporting group title |
only fasted state
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
fasted and fed state
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
only fasted state
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Reporting group description |
- | ||
Reporting group title |
fasted and fed state
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Reporting group description |
- |
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End point title |
concentration of abiraterone acetate [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
concentration of abiraterone acetate was measured during 4 hours
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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 1 subject could not be used |
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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 | ||
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: no adverse events were reported during this study |
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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/25592324 http://www.ncbi.nlm.nih.gov/pubmed/27061460 |