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NCT02354937 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02354937: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT02354937 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02354937, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance on overall 744 elimination, renal impairment may potentially inhibit some pathways of hepatic and gut drug metabolism and transport, and as a result may impact 744 pharmacokinetics. The current Food and Drug Administration (FDA) draft guidance for renal impairment studies suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted even for those drugs primarily metabolized or secreted in bile. The study will be comprised of two cohorts (severe renal impairment and normal renal function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study center and undergo serial PK sampling following a single dose of oral 744 30 milligrams (mg). Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744 30 mg dose.
Primary Outcome
To compare effect of severe renal impairment on PK parameters for 744 assessed by Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinity\]) and Maximum observed concentration (Cmax)
Interventions
- DRUG GSK1265744 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-07-13 |
| Est. Completion | 2016-11-01 |
| Phase | Phase 1 |
What the finished NCT02354937 record still lists
NCT02354937 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK1265744 30 mg is the first listed.
NCT02354937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02354937 about?
NCT02354937 is a clinical study titled "Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment". GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after a single 30 mg radiol...
What is the current status of trial NCT02354937?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-07-13. Estimated completion is 2016-11-01.
What interventions are being tested in trial NCT02354937?
The interventions under investigation include: GSK1265744 30 mg (DRUG).
Who is sponsoring clinical trial NCT02354937?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02354937's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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