A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2023-06-28

Brief Summary

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The purpose of this study is to assess safety and tolerability of multiple oral doses of GSBR-1290 (capsule) in healthy adult Japanese participants compared to non-Japanese participants.

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Detailed Description

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This is a multiple ascending dose (MAD) study in which 4 dose levels will be evaluated in 2 cohorts from Day 1 to Day 28 (4-week period). The starting dose of GSBR-1290 will be based on results from the single ascending dose (SAD) study (GSBR-1290-01) and MAD study (GSBR-1290-02 \[NCT05762471\]).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study drug (GSBR-1290 or placebo) administration in Cohort 1 is double-blind and Study drug (GSBR-1290) administration in Cohort 2 is open label.

Study Groups

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Cohort 1: GSBR-1290 or Placebo

Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.

Group Type EXPERIMENTAL

GSBR-1290

Intervention Type DRUG

Participants will receive GSBR-1290 oral capsules.

Placebo

Intervention Type OTHER

Participants will receive matching placebo oral capsules.

Cohort 2: GSBR-1290

Healthy non-Japanese participants (Caucasians or African Americans) will receive once daily doses of study drug (GSBR-1290 oral capsules) for up to 4 weeks.

Group Type EXPERIMENTAL

GSBR-1290

Intervention Type DRUG

Participants will receive GSBR-1290 oral capsules.

Interventions

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GSBR-1290

Participants will receive GSBR-1290 oral capsules.

Intervention Type DRUG

Placebo

Participants will receive matching placebo oral capsules.

Intervention Type OTHER

Other Intervention Names

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GSBR-1001290

Eligibility Criteria

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Inclusion Criteria

For Cohort 1 only:

1. Japanese participants must have both parents and 4 grandparents of Japanese origin

For Cohort 2 only:
2. Non-Japanese participants must not have parents and grandparents of Japanese origin. Non-Japanese participants will be limited to Caucasians of European and Latin American descent or African Americans

For Cohorts 1 and 2:
3. Must have given written informed consent before any study-related activities are carried out
4. Adult males and females, age 18 to 55 years of age (inclusive) at screening
5. Body Mass Index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 24.9 kilogram per square meter (kg/m\^2), with a body weight (to 1 decimal place) \>= 45.0 kg at screening
6. No nicotine use
7. Sitting blood pressure after resting for 5 minutes between 90 to 140 millimeter of mercury (mm Hg) systolic and 50 to 90 mm Hg diastolic and a heart rate between 40 to 100 beats per minute
8. Have suitable venous access for blood sampling

Exclusion Criteria

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months
2. Liver function test results elevated \> 2.0-fold the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate transaminase (AST) or alanine transaminase (ALT). Bilirubin above ULN
3. Estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute (mL/min)/1.73m\^2 body surface area
4. Known hypersensitivity to any of the study drug ingredients
5. Any other condition or prior therapy that would make the participant unsuitable for this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes