Assessment of the PK of BLU-5937 Prototypes and a Reference Formulation (QSC205919)
Research type
Research Study
Full title
A Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to assess the Pharmacokinetic Profile of BLU-5937 following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects
IRAS ID
1005081
Contact name
Nathalie Chauret
Contact email
Sponsor organisation
Bellus Health Inc.
Eudract number
2022-000396-39
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing a test medicine, BLU-5937, for the treatment of Refractory (or unexplained) Chronic Cough (RCC).
RCC is defined by a cough lasting longer than 8 weeks which has not responded to current treatments. This type of cough is thought to be due to the activation of a certain type of receptor in the upper airways which sends a signal of irritation to the brain that translates into an urge-to-cough.
This single-part healthy volunteer trial will compare how the body affects different formulations (recipes) of the test medicine (i.e., pharmacokinetics, PK). We will also look at the safety and tolerability of the test medicine formulations as well as the effect of food on how the test medicine is absorbed.
This study will take place at 1 non-NHS site and it is planned to enrol up to 16 male and female volunteers aged between 18 and 55 years. Volunteers will participate in 6 study periods.
In Period 1 and Periods 3 to 6, on the morning of Day 1, volunteers will receive a single oral dose of the test medicine formulations in the fed or fasted state. Different formulations or doses of the test medicine may be given in each period. In Period 2, volunteers will receive a single oral dose of the reference medicine formulation on two occasions, once in the morning and once in the evening (12 hours apart), in the fasted state.
Volunteers will be discharged on the evening of Day 2 of each period and there will be a minimum of 7 days between each dosing occasion. Volunteers will receive a follow up phone call approximately 7 days after the final dose.
Volunteer’s blood and urine samples will be taken throughout the study for analysis of the test medicine and/or for their safety.
Volunteers are expected to be involved in this study for approximately 20 weeks from screening until the follow up call.
REC name
HSC REC A
REC reference
22/NI/0132
Date of REC Opinion
20 Sep 2022
REC opinion
Further Information Favourable Opinion