Trial · NCT03882801

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

NCT03882801, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2020-11-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039). Trials, record NCT03882801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03882801

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
NCT number: NCT03882801
Status: Completed
Phases: Phase 1
Enrollment: 24 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Obstructive Sleep Apnea (OSA)
Interventions: Gefapixant, Placebo
First posted: 2019-03-20
Last updated: 2024-11-04
Other registries' IDs: eudract:2018-004099-37
Results first posted: 2020-11-19

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)	Day-1 at Baseline and Day 7 of each treatment period	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 (EMG), electrocardiogram (ECG), airflow, respiratory effort, oximetry, and sleep position data. Baseline AHI measurements in each period are obtained on Day -1. Individual AHI fold-change from baseline in each treatment period are calculated as the ratio of on-treatment AHI to baseline AHI.
Secondary	Number of Participants Who Experienced an Adverse Event (AE) During the Study	Up to 14 days after last dose of study drug (Up to 35 days)	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, is also an AE.
Secondary	Number of Participants Who Discontinued Study Drug Due to an AE	Up to 21 days	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, is also an AE.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)	Day-1 at Baseline and Day 7 of each treatment period	Analysis population consisted of all randomized participants who received at least 1 dose of study drug, were compliant with the study procedure and had available data.	ratio	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants Who Experienced an Adverse Event (AE) During the Study	Up to 14 days after last dose of study drug (Up to 35 days)	Any participant who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Discontinued Study Drug Due to an AE	Up to 21 days	Any participant who received at least 1 dose of study drug	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)	Placebo	0.86	95% Confidence Interval 0.68 to 1.09	ratio
Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)	Gefapixant 180 mg	0.97	95% Confidence Interval 0.74 to 1.27	ratio
Number of Participants Who Experienced an Adverse Event (AE) During the Study	Placebo	2		Participants
Number of Participants Who Experienced an Adverse Event (AE) During the Study	Gefapixant 180 mg	13		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Placebo	0		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Gefapixant 180 mg	1		Participants

Source ClinicalTrials.gov

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Placebo Then Gefapixant 180 mg	12
Period 1	STARTED	Gefapixant 180 mg Then Placebo	12
Period 1	Treated	Placebo Then Gefapixant 180 mg	11
Period 1	Treated	Gefapixant 180 mg Then Placebo	12
Period 1	COMPLETED	Placebo Then Gefapixant 180 mg	10
Period 1	COMPLETED	Gefapixant 180 mg Then Placebo	10
Period 1	NOT COMPLETED	Placebo Then Gefapixant 180 mg	2
Period 1	NOT COMPLETED	Gefapixant 180 mg Then Placebo	2
Washout Period	STARTED	Placebo Then Gefapixant 180 mg	10
Washout Period	STARTED	Gefapixant 180 mg Then Placebo	10

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events96

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arrhythmia	Cardiac disorders	Screening	0	24	0
other	Arrhythmia	Cardiac disorders	Gefapixant	0	22	0
other	Arrhythmia	Cardiac disorders	Placebo	1	20	1
other	Arrhythmia	Cardiac disorders	Post Trial	0	24	0
other	Dry mouth	Gastrointestinal disorders	Screening	0	24	0
other	Dry mouth	Gastrointestinal disorders	Gefapixant	1	22	1
other	Dry mouth	Gastrointestinal disorders	Placebo	0	20	0
other	Dry mouth	Gastrointestinal disorders	Post Trial	0	24	0
other	Dyspepsia	Gastrointestinal disorders	Screening	0	24	0
other	Dyspepsia	Gastrointestinal disorders	Gefapixant	1	22	1

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Screening	0	24
Total, all-cause mortality	Gefapixant	0	22
Total, all-cause mortality	Placebo	0	20
Total, all-cause mortality	Post Trial	0	24
Total, other adverse events	Screening	2	24
Total, other adverse events	Gefapixant	13	22
Total, other adverse events	Placebo	2	20
Total, other adverse events	Post Trial	1	24
Total, serious adverse events	Screening	0	24
Total, serious adverse events	Gefapixant	0	22

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39069967	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gefapixant 180 mg vs Placebo: Number of Participants Who Experienced an Adverse Event (AE) During the Study	Trial comparisons
Gefapixant 180 mg vs Placebo: Number of Participants Who Discontinued Study Drug Due to an AE	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03882801

GET https://conductscience.org/api/trials/v1/NCT03882801/events?page=2

API reference For AI assistants