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NCT04568603 · ClinicalTrials.gov registry record · Phase 1
Islatravir and Methadone Pharmacokinetics (MK-8591-029)
A Phase 1 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT04568603: Completed Phase 1 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
NCT04568603 is a Phase 1 study of HIV-1-infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 14 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04568603, a Phase 1 study of HIV-1-infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study Summary
The present study is designed to determine the effect of islatravir (ISL) \[MK-8591\] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve from dosing to 24 hours postdose (AUC0-24) of S-methadone and R-methadone in participants on oral methadone therapy. It is hypothesized that the plasma AUC0-24hr for S- and R-methadone will be similar after methadone alone compared to methadone and ISL 60 mg coadministration.
Primary Outcome
The AUC0-24 of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.
Conditions Studied
Interventions
- DRUG Islatravir
Study Locations (2)
Florida
- Research Centers of America, LLC ( Site 0002) - Hollywood
Utah
- PRA Health Sciences ( Site 0001) - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2021-07-09 |
| Phase | Phase 1 |
What the finished NCT04568603 record still lists
NCT04568603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (96% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which Islatravir is the first listed.
NCT04568603 reports a single indexed study location in Florida, Utah.
Frequently Asked Questions
What is clinical trial NCT04568603 about?
NCT04568603 is a clinical study titled "Islatravir and Methadone Pharmacokinetics (MK-8591-029)". The present study is designed to determine the effect of islatravir (ISL) \[MK-8591\] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve from dosing to 24 hours postdose (AUC0-24) of S-methadone and R-methadon...
What is the current status of trial NCT04568603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-10-16. Estimated completion is 2021-07-09.
What conditions does trial NCT04568603 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT04568603?
The interventions under investigation include: Islatravir (DRUG).
Who is sponsoring clinical trial NCT04568603?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04568603 being conducted?
This trial has 2 study locations across Florida, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04568603's enrollment target sits among peer trials
14 67th of 71 higher than 5 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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.
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