Clinical trial NCT05893043: A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-06-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[NCT05762471\]).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: From start of study drug up to End of study (EOS) (up to Day 42)
measure: Number of Participants Based on Severity of AEs
timeFrame: From start of study drug up to EOS (up to Day 42)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to EOS (Day 42)
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
timeFrame: Baseline up to EOS (Day 42)
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
timeFrame: Baseline up to EOS (Day 42)
Secondary outcomes:
measure: Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters
timeFrame: 31 days
measure: Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
timeFrame: 31 days
measure: Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
timeFrame: 31 days
measure: 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
timeFrame: 31 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACT
state: California
Study officials:
References: