Clinical trial NCT06139055: A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.
2. Healthy overweight or obese adult men and women.
3. Age greater then or equal to (\>=)18 and less than or equal to (\<=) 75 years.
4. Body mass index (BMI) \>=27.0 kilogram per square meter (kg/m\^2).

Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease.

Primary outcomes:
measure: 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
timeFrame: From start of study drug up to Day 10
measure: 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
timeFrame: From start of study drug up to Day 10
measure: 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
timeFrame: From start of study drug up to Day 10
measure: 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
timeFrame: From start of study drug up to Day 10
measure: 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
timeFrame: From start of study drug up to Day 10
measure: 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
timeFrame: From start of study drug up to Day 10
measure: 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
timeFrame: From start of study drug up to Day 10
measure: Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: From start of study drug up to End of study (EOS) in Part 2 (up to Day 98)
measure: Part 2: Number of Participants With Severity of AEs
timeFrame: From start of study drug up to EOS in Part 2 (up to Day 98)
measure: Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: From start of study drug up to EOS in Part 2 (up to Day 98)
measure: Part 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
timeFrame: From start of study drug up to EOS in Part 2 (up to Day 98)
measure: Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
timeFrame: From start of study drug up to EOS in Part 2 (up to Day 98)
Secondary outcomes:
measure: Part 1: Number of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: From start of study drug up to EOS in Part 1 (Day 17)
measure: Part 1: Number of Participants Based on Severity of AEs
timeFrame: From start of study drug up to EOS in Part 1 (Day 17)
measure: Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to EOS in Part 1 (Day 17)
measure: Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
timeFrame: Baseline up to EOS in Part 1 (Day 17)
measure: Part 1: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
timeFrame: Baseline up to EOS in Part 1 (Day 17)
measure: Part 2: Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters
timeFrame: From start of study drug up to Day 84
measure: Part 2: 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: From start of study drug up to Day 84
measure: Part 2: Analysis of Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (24 hours) at Steady State (AUC0-tau) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
timeFrame: From start of study drug up to Day 84
measure: Part 2: Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
timeFrame: From start of study drug up to Day 84
measure: Part 2: Analysis of Apparent Terminal Elimination Half-life (t1/2) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
timeFrame: From start of study drug up to Day 84
Other outcomes:
Locations:
city: Miami
country: United States
facility: ERG Clinical (Clinical Pharmacology of Miami - CPMI)
state: Florida
city: Miami
country: United States
facility: Syneos Miami Site
state: Florida
city: Baltimore
country: United States
facility: Parexel Baltimore Early Phase Clinical Unit
state: Maryland
Study officials:
References: