NCT03882801

Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)

A Randomized Double Blind Clinical Trial to Evaluate the Effects of MK-7264 in Participants With Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DRUG	Gefapixant	In Periods 1 and 2 (7 days each) participants receive 4 tablets (180 mg) of gefapixant (MK-7264) QHS.
DRUG	Placebo	In Periods 1 and 2 (7 days each) participants receive 4 tablets of placebo QHS.

Timeline

• Start date: 2019-04-10
• Primary completion: 2019-10-22
• Completion: 2019-10-22
• First posted: 2019-03-20
• Last updated: 2024-11-04
• Results posted: 2020-11-19

Locations

5 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study