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

NCT03638180 | Completed Phase 1 DMC

• 1 other identifier: BUS-P5-703
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• Number and severity of treatment emergent adverse events (TEAEs)

  Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose

  up to 48 hours after the last dose

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  up to 48 hours after the last dose

• Area under the curve (AUC)

  up to 48 hours after the last dose

• Maximum plasma concentration (Cmax) under fed conditions

  up to 48 hours after the last dose

• Area under the curve (AUC) under fed conditions

  up to 48 hours after the last dose

Study Arms (2)

Single Ascending Doses

EXPERIMENTAL

Single ascending doses, 6 dose levels

Drug: BLU-5937; Drug: Placebo

Multiple Ascending Doses

EXPERIMENTAL

Multiple ascending doses, 3 dose levels

Drug: BLU-5937; Drug: Placebo

Interventions

BLU-5937 DRUG

BLU-5937 oral tablet

Multiple Ascending Doses; Single Ascending Doses

Placebo DRUG

Matching placebo to BLU-5937

Multiple Ascending Doses; Single Ascending Doses

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (1)

Alta Sciences Algorithme Pharma

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Cough

Interventions

BLU-5937

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 20, 2018
• Study Start: July 9, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-08

Locations

CA (1)