NCT06179537 - Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects | Crick | Crick

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

Phase 1CompletedNCT06179537

Bellus Health Inc. - a GSK company34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

34

Conditions

Interventions

Single and multiple doses assessment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Richmond Pharmacology Ltd.

London, United Kingdom

Outcomes

Primary Outcomes

Assessment of ECG QTcF interval (ms) change

Time frame: 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

Assessment of heart rate (BPM) change

Time frame: 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

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

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)

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

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

Data from ClinicalTrials.gov

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