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NCT01715259 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
A Phase 1 study of Renal Insufficiency, sponsored by Cougar Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01715259: Completed Phase 1 study of Renal Insufficiency, sponsored by Cougar Biotechnology.
NCT01715259 is a Phase 1 study of Renal Insufficiency that has completed, run by Cougar Biotechnology. The registered enrollment target is 16 participants, below the 101-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01715259, a Phase 1 study of Renal Insufficiency, has completed, sponsored by Cougar Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.
Conditions Studied
Interventions
- DRUG Abiraterone acetate: participants with end-stage renal disease
- DRUG Abiraterone acetate: matched control participants with normal renal function
Study Locations (1)
Florida
- - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-01 |
| Phase | Phase 1 |
What the finished NCT01715259 record still lists
NCT01715259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 101-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Renal Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which Abiraterone acetate: participants with end-stage renal disease is the first listed.
NCT01715259 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01715259 about?
NCT01715259 is a clinical study titled "A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function". The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.
What is the current status of trial NCT01715259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2009-08. Estimated completion is 2010-01.
What conditions does trial NCT01715259 study?
This clinical trial studies the following conditions: Renal Insufficiency.
What interventions are being tested in trial NCT01715259?
The interventions under investigation include: Abiraterone acetate: participants with end-stage renal disease (DRUG), Abiraterone acetate: matched control participants with normal renal function (DRUG).
Who is sponsoring clinical trial NCT01715259?
This trial is sponsored by Cougar Biotechnology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01715259 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01715259's enrollment target sits among peer trials
16 22nd of 22 higher than 1 of 22 other Renal Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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