Healthy Volunteers
Conditions
Brief summary
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.
Detailed description
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 \[NCT05762471\]).
Interventions
DRUGGSBR-1290
Participants will receive GSBR-1290 oral capsules.
OTHERPlacebo
Participants will receive matching placebo oral capsules.
Sponsors
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | Baseline up to EOS (Day 42) |
| Number of Participants With Adverse Events (AEs) and Serious AEs | From start of study drug up to End of study (EOS) (up to Day 42) |
| Number of Participants Based on Severity of AEs | From start of study drug up to EOS (up to Day 42) |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to EOS (Day 42) |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline up to EOS (Day 42) |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters | 31 days |
| Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters | 31 days |
| Analysis of Area Under the Plasma Concentration-time Curve (AUC) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters | 31 days |
| Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters | 31 days |
Countries
United States
Outcome results
None listed