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

Bellus Health

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BLU-5937

Study type: Interventional

Funder types: Industry

Identifiers

NCT06179537

BUS-P1-07

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: BLU-5937

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: BLU-5937

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: BLU-5937