PK and Safety study following multiple doses of BLU-5937
Research type
Research Study
Full title
A Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses
IRAS ID
298739
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Bellus Health Cough Inc.
Eudract number
2021-002811-71
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 14 days
Research summary
BLU-5937 is an investigational drug under development for the treatment of refractory or unexplained persistent cough. It has previously been successfully dosed in volunteers in Phase 1 and Phase 2 studies and has been shown to have a favourable safety and tolerability profile.
Chronic cough has been estimated as affecting 11-13% of the population. Richmond Pharmacology are conducting a clinical trial aimed at investigating the relative bioavailability of BLU-5937 in Japanese and Caucasian subjects. The study will involve 34 healthy volunteers; 26 Japanese and eight Caucasian. The volunteers will have a residential stay of 12 days, receiving the investigational drug or placebo once on Day 1, twice daily on Days 3-8 and once on Day 9.
The main objective of the study is to establish the safety and tolerability of BLU-5937 following single and multiple dosing in healthy adult Japanese and Caucasian subjects. Additionally, the data collected in this study will help to establish whether BLU-5937 is metabolised by the body in similar fashions in Japanese populations when compared to Caucasians.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0408
Date of REC Opinion
30 Jun 2021
REC opinion
Favourable Opinion