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

Bellus Health

Status and phase: Completed; Phase 1

Conditions: Cough

Treatments: Drug: Placebo; Drug: BLU-5937

Study type: Interventional

Funder types: Industry

Identifiers

NCT03638180

BUS-P5-703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Single Ascending Doses

Experimental group

Description:

Single ascending doses, 6 dose levels

Treatment:

Drug: Placebo

Drug: BLU-5937

Multiple Ascending Doses

Experimental group

Description:

Multiple ascending doses, 3 dose levels

Treatment:

Drug: Placebo

Drug: BLU-5937