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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06139055
• Other study ID #: GSBR-1290-05
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 2, 2023
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Gasherbrum Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Overweight

Intervention

Drug:
• GSBR-1290 (Capsule/Tablet)
Participants will receive GSBR-1290 oral capsules or tablets.
• GSBR-1290
Participants will receive GSBR-1290 oral tablets.
• Placebo
Participants will receive matching-placebo oral tablets.
• Placebo (Capsule/Tablet)
Participants will receive matching-placebo oral capsules or tablets.

Locations

Country	Name	City	State
United States	Parexel Baltimore Early Phase Clinical Unit	Baltimore	Maryland
United States	ERG Clinical (Clinical Pharmacology of Miami - CPMI)	Miami	Florida
United States	Syneos Miami Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gasherbrum Bio, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	Part 2: Number of Participants With Severity of AEs		From start of study drug up to EOS in Part 2 (up to Day 98)
Primary	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)
Primary	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)
Primary	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)
Secondary	Part 1: Number of Participants With Adverse Events (AEs) and Serious AEs		From start of study drug up to EOS in Part 1 (Day 17)
Secondary	Part 1: Number of Participants Based on Severity of AEs		From start of study drug up to EOS in Part 1 (Day 17)
Secondary	Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs		Baseline up to EOS in Part 1 (Day 17)
Secondary	Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters		Baseline up to EOS in Part 1 (Day 17)
Secondary	Part 1: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters		Baseline up to EOS in Part 1 (Day 17)
Secondary	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		From start of study drug up to Day 84
Secondary	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		From start of study drug up to Day 84
Secondary	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		From start of study drug up to Day 84
Secondary	Part 2: Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters		From start of study drug up to Day 84
Secondary	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		From start of study drug up to Day 84