A 2-part, Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Comparative Bioavailability of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants

Registration

Registration

NCT06139055

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

QUADRUPLE

Status

UNKNOWN

Enrollment

70

Start

2023-10-02

Primary completion

2024-03

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Conditions

Healthy Volunteers

Interventions

DRUG:GSBR-1290 (Capsule/Tablet); DRUG:GSBR-1290; DRUG:Placebo; DRUG:Placebo (Capsule/Tablet)

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Part 1: Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters [From start of study drug up to Day 10]
• Part 1: Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [From start of study drug up to Day 10]
• Part 1: Analysis of Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [From start of study drug up to Day 10]
• Part 1: Analysis of Area Under the Plasma Concentration-time Curve From 0 to infinity (AUC0-inf) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [From start of study drug up to Day 10]
• Part 1: Analysis of Apparent Terminal Elimination Half-life (t1/2) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [From start of study drug up to Day 10]
• Part 1: Analysis of Total Apparent Body Clearance (CL/F) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [From start of study drug up to Day 10]
• Part 1: Analysis of Apparent Volume of Distribution (Vz/F) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [From start of study drug up to Day 10]
• Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs [From start of study drug up to End of study (EOS) in Part 2 (up to Day 98)]
• Part 2: Number of Participants With Severity of AEs [From start of study drug up to EOS in Part 2 (up to Day 98)]
• Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs [From start of study drug up to EOS in Part 2 (up to Day 98)]
• Part 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [From start of study drug up to EOS in Part 2 (up to Day 98)]
• Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [From start of study drug up to EOS in Part 2 (up to Day 98)]