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NCT03882801 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03882801: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03882801 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03882801, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA). The primary hypothesis is that multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe OSA reduces the Apnea Hypopnea Index (AHI) relative to placebo.
Primary Outcome
The apnea-hypopnea index (AHI) is the sum of the apnea and hypopnea indices for each participant. The apnea index for each participant is calculated as the number of apneas divided by the total sleep time. The hypopnea index for each participant is calculated as the number of hypopneas divided by the total sleep time. These measurements are collected from polysonagraphs (PSGs), which are diagnostic sleep studies that collect electroencephalogram (EEG), electrooculograph (EOG), electromyogram (EM
Interventions
- DRUG Placebo
- DRUG Gefapixant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2019-10-22 |
| Phase | Phase 1 |
What the finished NCT03882801 record still lists
NCT03882801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03882801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03882801 about?
NCT03882801 is a clinical study titled "Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)". The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA). The primary hypothesis is that multiple dose administration of gefapixant (MK-7264) in participants with m...
What is the current status of trial NCT03882801?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-04-10. Estimated completion is 2019-10-22.
What interventions are being tested in trial NCT03882801?
The interventions under investigation include: Placebo (DRUG), Gefapixant (DRUG).
Who is sponsoring clinical trial NCT03882801?
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 NCT03882801's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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