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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Acute Cough

Treatments: Drug: Placebo; Drug: Gefapixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03569033

7264-013

MK-7264-013 (Other Identifier)

2017-000472-28 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Gefapixant 45 mg BID

Experimental group

Description:

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

Treatment:

Drug: Gefapixant

Placebo BID

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo