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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2018-10-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Ascending Doses

Single ascending doses, 6 dose levels

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

BLU-5937 oral tablet

Placebo

Intervention Type DRUG

Matching placebo to BLU-5937

Multiple Ascending Doses

Multiple ascending doses, 3 dose levels

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

BLU-5937 oral tablet

Placebo

Intervention Type DRUG

Matching placebo to BLU-5937

Interventions

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BLU-5937

BLU-5937 oral tablet

Intervention Type DRUG

Placebo

Matching placebo to BLU-5937

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes