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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03638180

Enrollment

Registered

2018-08-20

Start date

2018-07-09

Completion date

2018-10-25

Last updated

2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

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.

Interventions

DRUGBLU-5937

BLU-5937 oral tablet

DRUGPlacebo

Matching placebo to BLU-5937

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026