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

May 16, 2025 updated by: Bellus Health Inc. - a GSK company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Release formulation
IR Formulation
Drug: BLU-5937 IR
Each subject will receive two single and multiple administrations of Immediate Release reference formulation
Experimental: Extended Release formulation
ER formulation
Drug: BLU-5937 ER
Each subject will receive single and multiple oral administrations of Extended Release formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the maximum observed plasma drug concentration (Cmax)
Time Frame: Pre dose up to 36 hours post-dose
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)
Time Frame: Pre dose up to 36 hours post-dose
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
Time Frame: Pre dose up to 36 hours post-dose
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)
Time Frame: 24 hours post-dose
To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bellus Health Inc. - a GSK company

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 222418
  • BUS-P1-09 (Other Identifier: Bellus Health Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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