Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation

NCT05570539 | Completed Phase 1 FDA Drug

• 2 other identifiers: 222418BUS-P1-09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects

Conditions

Cough; Healthy

Outcome Measures

Primary Outcomes (4)

• Measurement of the maximum observed plasma drug concentration (Cmax)

  To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

  Pre dose up to 36 hours post-dose

• Measurement of the minimum observed plasma drug concentration (Cmin)

  To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

  Pre dose up to 36 hours post-dose

• Measurement of the area under the plasma drug concentration by time curve AUC

  To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

  Pre dose up to 36 hours post-dose

• Measurement of the observed plasma drug concentration 24 hours post-dose (C24)

  To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

  24 hours post-dose

Study Arms (2)

Immediate Release formulation

ACTIVE COMPARATOR

IR Formulation

Drug: BLU-5937 IR

Extended Release formulation

EXPERIMENTAL

ER formulation

Drug: BLU-5937 ER

Interventions

BLU-5937 IR DRUG

Each subject will receive two single and multiple administrations of Immediate Release reference formulation

Immediate Release formulation

BLU-5937 ER DRUG

Each subject will receive single and multiple oral administrations of Extended Release formulation

Extended Release formulation

Eligibility Criteria

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

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females

You may not qualify if:

• History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (1)

GSK Investigational Site

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 7, 2022
• Primary Completion: May 2, 2024
• Study Completion: July 1, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)