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

NCT06179537 | Completed Phase 1 FDA Drug

• 1 other identifier: BUS-P1-07
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Assessment of ECG QTcF interval (ms) change

  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

• 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

• Number of participants with clinically significant changes in Physical Examination

  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

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo.

Drug: BLU-5937

Cohort 3

EXPERIMENTAL

8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo.

Drug: BLU-5937

Interventions

BLU-5937 DRUG

Single and multiple doses assessment

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 45 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 neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (1)

Richmond Pharmacology Ltd.

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Interventions

BLU-5937

Study Design

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

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 22, 2023
• Study Start: August 6, 2021
• Primary Completion: October 22, 2021
• Study Completion: November 21, 2021
• Last Updated: December 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)