Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

NCT03569033 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 7264-013MK-7264-0132017-000472-28
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).

Conditions

Acute Cough

Outcome Measures

Primary Outcomes (1)

• Awake Coughs Per Hour on Day 3

  Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.

  Day 3

Secondary Outcomes (5)

• Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3

  Baseline and Day 3

• Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3

  Baseline and Day 3

• Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3

  Baseline and Day 3

• Percentage of Participants Who Experienced One or More Adverse Events (AEs)

  Up to 21 days

• Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)

  Up to Day 7

Study Arms (2)

Gefapixant 45 mg BID

EXPERIMENTAL

Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.

Drug: Gefapixant

Placebo BID

PLACEBO COMPARATOR

Participants will receive a matching placebo tablet BID for 7 days.

Drug: Placebo

Interventions

Gefapixant DRUG

Gefapixant 45 mg will be administered orally.

Also known as: MK-7264

Gefapixant 45 mg BID

Placebo DRUG

Placebo tablet matching gefapixant will be administered orally.

Placebo BID

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In good general health
• Susceptible to human rhinovirus type 16 (HRV-16)
• Male or non-pregnant and non-breast feeding female
• If female of reproductive potential, agrees to use 1 form of acceptable birth control

You may not qualify if:

• Donated blood within 56 days or donated plasma within 7 days prior to dosing
• History of significant multiple and/or severe allergies
• Recent history of respiratory tract infection
• History of cancer
• Body mass index \<18 kg/m\^2 or ≥40 kg/m\^2
• History of major surgery or loss of 1 unit of blood
• History of allergic reaction to sulfonamides
• Received medications within 14 days prior to randomization
• Significantly abnormal laboratory tests at Screening
• Current smoker, smoked within 5 years of Screening, or significant past smoking history
• History of alcohol or drug abuse

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)

London, E1 2AX, United Kingdom

Location

Related Publications (1)

• Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15.

  PMID: 35969360 DERIVED

MeSH Terms

Interventions

Gefapixant

Limitations and Caveats

This study was terminated because the data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: July 4, 2018
• Primary Completion: October 31, 2018
• Study Completion: November 19, 2018
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)