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NCT04303156 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04303156: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04303156 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04303156, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health.
Primary Outcome
Participants were treated with islatravir (ISL), and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values.
Interventions
- DRUG Islatravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2020-10-19 |
| Phase | Phase 1 |
What the finished NCT04303156 record still lists
NCT04303156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Islatravir is the first listed.
NCT04303156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04303156 about?
NCT04303156 is a clinical study titled "Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)". This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health.
What is the current status of trial NCT04303156?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-06-18. Estimated completion is 2020-10-19.
What interventions are being tested in trial NCT04303156?
The interventions under investigation include: Islatravir (DRUG).
Who is sponsoring clinical trial NCT04303156?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04303156's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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