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

Cough Clinical Trial

Official title:

A Double-Blind, Placebo Controlled, Randomized, Adaptive, First-in-Human Study to Assess, Safety, Tolerability, Pharmacokinetics and Food Effect of Single and Multiple Doses of BLU-5937 Administered Orally in Healthy Male and Female

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638180
• Other study ID #: BUS-P5-703
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: August 2018
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• BLU-5937
BLU-5937 oral tablet
• Placebo
Matching placebo to BLU-5937

Locations

Country	Name	City	State
Canada	Alta Sciences Algorithme Pharma	Mount-Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of treatment emergent adverse events (TEAEs)	Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose	up to 48 hours after the last dose
Secondary	Maximum plasma concentration (Cmax)	To assess Cmax of single and multiple ascending oral doses of BLU-5937	up to 48 hours after the last dose
Secondary	Area under the curve (AUC)	To assess AUC of single and multiple ascending oral doses of BLU-5937	up to 48 hours after the last dose
Secondary	Maximum plasma concentration (Cmax) under fed conditions	To assess Cmax of a single oral dose of BLU-5937 under fed conditions	up to 48 hours after the last dose
Secondary	Area under the curve (AUC) under fed conditions	To assess AUC of a single oral dose of BLU-5937 under fed conditions	up to 48 hours after the last dose