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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BLU-5937

• Registration Number: NCT06179537
• Lead Sponsor: Bellus Health Inc. - a GSK company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-06
• Primary Completion: 2021-10-22
• Study Completion: 2021-11-21
• Status Verified: 2023-11
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2023-12-22
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	BLU-5937	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.
Cohort 2	BLU-5937	8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo.
Cohort 3	BLU-5937	8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo.

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically significant changes in Clinical laboratory tests	Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of ECG QTcF interval (ms) change	Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Physical Examination	Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of diastolic and systolic blood pressure (mmHg) change	Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of heart rate (BPM) change	Pre-dose up to 48 hours post-dose for both single and multiple administration
Adverse Event and Adverse Event of medical interest monitoring	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)	Pre-dose up to 48 hours post-dose for both single and multiple administration
Measurement of the maximum observed plasma drug concentration (Cmax)	Pre-dose up to 48 hours post-dose for both single and multiple administration

Trial Locations

Locations (1)

Richmond Pharmacology Ltd.; 🇬🇧 London, United Kingdom