Status:
ACTIVE_NOT_RECRUITING
A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants
Lead Sponsor:
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.
- Healthy overweight or obese adult men and women.
- Age greater then or equal to (\>=)18 and less than or equal to (\<=) 75 years.
- Body mass index (BMI) \>=27.0 kilogram per square meter (kg/m\^2).
Exclusion
- 1\. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06139055
Start Date
October 2 2023
End Date
March 1 2024
Last Update
February 15 2024
Active Locations (3)
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1
ERG Clinical (Clinical Pharmacology of Miami - CPMI)
Miami, Florida, United States, 33014
2
Syneos Miami Site
Miami, Florida, United States, 33131
3
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225