BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect

Phase 1

Completed

• Conditions: Cough
• Interventions: Drug: BLU-5937; Drug: Placebo

• Registration Number: NCT03638180
• Lead Sponsor: Bellus Health Inc. - a GSK company

Brief Summary

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.

Detailed Description

BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.

Study Timeline

• Study Start: 2018-07-09
• Status Verified: 2018-08
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Healthy adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence),
• Age: 18 to 55 years (inclusive).
• Body mass index (BMI) : ≥18.5 and ≤30 kg/m².
• Non or ex smoker.

Exclusion Criteria

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) outside from normal and deemed by the investigator to be clinically significant.
• Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy.
• Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration.
• Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration.
• Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Ascending Doses	Placebo	Single ascending doses, 6 dose levels
Multiple Ascending Doses	BLU-5937	Multiple ascending doses, 3 dose levels
Multiple Ascending Doses	Placebo	Multiple ascending doses, 3 dose levels
Single Ascending Doses	BLU-5937	Single ascending doses, 6 dose levels

Primary Outcome Measures

Name	Time	Method
Number and severity of treatment emergent adverse events (TEAEs)	up to 48 hours after the last dose	Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose

Secondary Outcome Measures

Name	Time	Method
Area under the curve (AUC) under fed conditions	up to 48 hours after the last dose	To assess AUC of a single oral dose of BLU-5937 under fed conditions
Maximum plasma concentration (Cmax)	up to 48 hours after the last dose	To assess Cmax of single and multiple ascending oral doses of BLU-5937
Area under the curve (AUC)	up to 48 hours after the last dose	To assess AUC of single and multiple ascending oral doses of BLU-5937
Maximum plasma concentration (Cmax) under fed conditions	up to 48 hours after the last dose	To assess Cmax of a single oral dose of BLU-5937 under fed conditions

Trial Locations

Locations (1)

Alta Sciences Algorithme Pharma; 🇨🇦 Mount-Royal, Quebec, Canada