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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01715259
The ClinicalTrials.gov registry entry for NCT01715259 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 101-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (84% lower). The listed sponsor is Cougar Biotechnology, which has 9 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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