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NCT02400307 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02400307: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT02400307 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02400307, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index \[BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m\^2)\] with a participant in the control group.
Primary Outcome
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Interventions
- DRUG Bictegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-04-17 |
| Est. Completion | 2015-07-13 |
| Phase | Phase 1 |
What the finished NCT02400307 record still lists
NCT02400307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Bictegravir is the first listed.
NCT02400307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02400307 about?
NCT02400307 is a clinical study titled "Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function". The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age ...
What is the current status of trial NCT02400307?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2015-04-17. Estimated completion is 2015-07-13.
What interventions are being tested in trial NCT02400307?
The interventions under investigation include: Bictegravir (DRUG).
Who is sponsoring clinical trial NCT02400307?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02400307's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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