Clinical trial NCT03638180: BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cough
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and severity of treatment emergent adverse events (TEAEs)
timeFrame: up to 48 hours after the last dose
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 48 hours after the last dose
measure: Area under the curve (AUC)
timeFrame: up to 48 hours after the last dose
measure: Maximum plasma concentration (Cmax) under fed conditions
timeFrame: up to 48 hours after the last dose
measure: Area under the curve (AUC) under fed conditions
timeFrame: up to 48 hours after the last dose
Other outcomes:
Locations:
city: Mount-Royal
country: Canada
facility: Alta Sciences Algorithme Pharma
state: Quebec
Study officials:
References: