CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Gefapixant +1 moredrug
Likely dose
Gefapixant 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03882801
NCT03882801Phase 1Completed
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A Randomized Double Blind Clinical Trial to Evaluate the Effects of MK-7264 in Participants With Obstructive Sleep Apnea

Merck Sharp & Dohme LLC·interventional·Posted Mar 20, 2019·Updated Nov 4, 2024

In Brief

A Phase 1 clinical trial evaluating Gefapixant and Placebo for Obstructive Sleep Apnea (OSA). Completed, enrolled 24 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea (OSA)
CountriesBelgium, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMar 20, 2019
Enrollment StartApr 10, 2019
Primary CompletionOct 22, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago

Interventions

Gefapixantdrug

In Periods 1 and 2 (7 days each) participants receive 4 tablets (180 mg) of gefapixant (MK-7264) QHS.

Placebodrug

In Periods 1 and 2 (7 days each) participants receive 4 tablets of placebo QHS.