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.
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 \[NCT05762471\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
18
ACT
Anaheim, California, United States
Number of Participants With Adverse Events (AEs) and Serious AEs
Time frame: From start of study drug up to End of study (EOS) (up to Day 42)
Number of Participants Based on Severity of AEs
Time frame: From start of study drug up to EOS (up to Day 42)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to EOS (Day 42)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to EOS (Day 42)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Time frame: Baseline up to EOS (Day 42)
Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters
Time frame: 31 days
Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Time frame: 31 days
Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Time frame: 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
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Time frame: 31 days