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

Sponsor

Gasherbrum Bio, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06139055

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

23.3

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: GSBR-1290 (Capsule/Tablet) Drug: GSBR-1290 Drug: Placebo Drug: Placebo (Capsule/Tablet)	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Part 1 is open-label, 2-period, 2-sequence, cross-over and Part 2 is double blinded

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 Tablet Participants will receive a single dose of GSBR-1290 oral capsule formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral tablet formulation on Day 8 (Day 1 of Treatment Period 2).	Drug: GSBR-1290 (Capsule/Tablet) Participants will receive GSBR-1290 oral capsules or tablets.
Experimental: Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 Capsule Participants will receive a single dose of GSBR-1290 oral tablet formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral capsule formulation on Day 8 (Day 1 of Treatment Period 2).	Drug: GSBR-1290 (Capsule/Tablet) Participants will receive GSBR-1290 oral capsules or tablets.
Experimental: Part 2 (Cohort 1): GSBR-1290/Placebo Tablet Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.	Drug: GSBR-1290 Participants will receive GSBR-1290 oral tablets. Drug: Placebo Participants will receive matching-placebo oral tablets.
Experimental: Part 2 (Cohort 2): GSBR-1290/Placebo Tablet Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.	Drug: GSBR-1290 Participants will receive GSBR-1290 oral tablets. Drug: Placebo Participants will receive matching-placebo oral tablets.
Experimental: Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks. In the last 4 weeks, participants will be further randomized to GSBR-1290 capsules or tablets or matching-placebo at Week 9 to 10 followed by alternate (capsule or tablet) formulation of either GSBR-1290 or placebo at Week 11 to 12.	Drug: GSBR-1290 (Capsule/Tablet) Participants will receive GSBR-1290 oral capsules or tablets. Drug: Placebo (Capsule/Tablet) Participants will receive matching-placebo oral capsules or tablets.

Outcome Measures

Primary Outcome Measures

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)]

Secondary Outcome Measures

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)]
Part 1: Number of Participants Based on Severity of AEs [From start of study drug up to EOS in Part 1 (Day 17)]
Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Baseline up to EOS in Part 1 (Day 17)]
Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [Baseline up to EOS in Part 1 (Day 17)]
Part 1: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [Baseline up to EOS in Part 1 (Day 17)]
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]
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]
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]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Gasherbrum Bio, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gasherbrum Bio, Inc

ClinicalTrials.gov Identifier:

NCT06139055

Other Study ID Numbers:

GSBR-1290-05

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Nov 18, 2023