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

Study Overview
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Brief Summary
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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

Official Title
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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
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Healthy

Intervention / Treatment
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* Drug: BLU-5937


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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<br>* Single and multiple doses assessment<br>|
| Experimental: Cohort 2<br>8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo. | Drug: BLU-5937<br>* Single and multiple doses assessment<br>|
| Experimental: Cohort 3<br>8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo. | Drug: BLU-5937<br>* Single and multiple doses assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |