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

NCT ID: NCT06179537

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2021-11-21

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

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.

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

Single and multiple doses assessment

Cohort 2

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

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

Single and multiple doses assessment

Cohort 3

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

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

Single and multiple doses assessment

Interventions

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BLU-5937

Single and multiple doses assessment

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bellus Health Inc. - a GSK company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Richmond Pharmacology Ltd.

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BUS-P1-07

Identifier Type: -

Identifier Source: org_study_id