Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects

December 19, 2023 updated by: Bellus Health Inc. - a GSK company

A Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses

This is a Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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
      • London, United Kingdom, SE1 1YR
        • Richmond Pharmacology Ltd.

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • History of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
10 Japanese and 8 Caucasian subjects. 8 out of 10 Japanese subjects will receive BLU-5937 Dose A and 2 will receive placebo. All Caucasian subjects will receive BLU-5937 Dose A.
Drug: BLU-5937
Single and multiple doses assessment
Experimental: Cohort 2
8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo.
Drug: BLU-5937
Single and multiple doses assessment
Experimental: Cohort 3
8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo.
Drug: BLU-5937
Single and multiple doses assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of ECG QTcF interval (ms) change
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of diastolic and systolic blood pressure (mmHg) change
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of heart rate (BPM) change
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Clinical laboratory tests
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Physical Examination
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration
Adverse Event and Adverse Event of medical interest monitoring
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
Measurement of the area under the plasma concentration by time curve (AUC)
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration
Measurement of the maximum observed plasma drug concentration (Cmax)
Time Frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Pre-dose up to 48 hours post-dose for both single and multiple administration

Collaborators and Investigators

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

Sponsor

Bellus Health Inc. - a GSK company

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)

August 6, 2021

Primary Completion (Actual)

October 22, 2021

Study Completion (Actual)

November 21, 2021

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BUS-P1-07

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

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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