MK-7264 on cough with induced viral upper respiratory tract infection
Research type
Research Study
Full title
A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants with Induced Viral Upper Respiratory Tract Infection
IRAS ID
239692
Contact name
Pratiksha Dokhe
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-000472-28
Clinicaltrials.gov Identifier
123007, IND no.
Duration of Study in the UK
0 years, 11 months, 7 days
Research summary
Cough is one of the most common presenting symptoms for patients. Current therapies for cough have limited effectiveness and undesirable side effects.
P2X3 purinergic receptors are expressed in the airways and, when activated by binding Adenosine Triphosphate (ATP), cause sensitisation of the airways resulting in a cough.
The drug to be tested in this study is MK-7264 which is a P2X3 receptor antagonist. MK-7264 can bind to P2X3 receptors, preventing ATP binding and thereby prevent the cough response from occurring.
This trial aims to provide proof of concept for use of MK-7264 in the treatment of acute (short term) cough; positive results in this trial will support continued development of MK-7264.
In this study, healthy adult volunteers will be infected with a virus to induce cough immediately before receiving treatment with either MK-7264 or placebo (dummy drug). Cough frequency will then be measured using a cough-counting device to compare frequency in participants treated with MK-7264 as compared to placebo.
There are two stages to the study:
Stage 1 -
50 participants will receive MK-7264 45 mg twice daily or a placebo.
Stage 2 -
100 to 138 Participants will receive 15 or 45 mg MK-7264 or placebo twice daily.
The MK-7264 15 mg treatment group is applicable only if a decision is made to add a MK-7264 lower dose group based on analysis of Stage 1 results.Approximately 188 participants will be enrolled into this study which will last approximately 45 weeks. Each participant will be in the study for approximately 50 days, about 9 days of which they will be required to spend in the study clinic. The study will take place at sites in the UK and is funded by Merck Sharp & Dohme Corp., a subsidiary of Merck Sharp & Dohme Co., Inc.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0081
Date of REC Opinion
1 Jun 2018
REC opinion
Further Information Favourable Opinion