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

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

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.

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.

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.