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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 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 19 participants.
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.
Interventions
- DRUG Bictegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-04-17 |
| Est. Completion | 2015-07-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02400307
The ClinicalTrials.gov registry entry for NCT02400307 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bictegravir is the first listed.
NCT02400307 reports 0 study locations.
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.
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