NCT06139055

A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety, tolerability, pharmacokinetic (PK), and comparative bioavailability of repeated administration of GSBR-1290 in healthy overweight/obese participants.

Detailed description

This is a 2-part study in which Part 1 will compare the PK of GSBR-1290, administered as tablet and capsule, using a 2-period, 2-sequence, crossover design in approximately 16 healthy overweight/obese participants. Part 2 will evaluate multiple-ascending doses of GSBR-1290 tablet in 3 cohorts, using 3 different titration regimens. Secondly in Part 2, the study will evaluate the comparative bioavailability of GSBR-1290 tablet versus capsule at a potentially clinically efficacious dose at steady state in Cohort 3.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GSBR-1290 (Capsule/Tablet)	Participants will receive GSBR-1290 oral capsules or tablets.
DRUG	GSBR-1290	Participants will receive GSBR-1290 oral tablets.
DRUG	Placebo	Participants will receive matching-placebo oral tablets.
DRUG	Placebo (Capsule/Tablet)	Participants will receive matching-placebo oral capsules or tablets.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-11-18
• Last updated: 2024-02-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study