NCT06139055

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

November 14, 2023

Last Update Submit

February 14, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (10)

  • 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)

  • +5 more secondary outcomes

Study Arms (5)

Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 Tablet

EXPERIMENTAL

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)

Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 Capsule

EXPERIMENTAL

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)

Part 2 (Cohort 1): GSBR-1290/Placebo Tablet

EXPERIMENTAL

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.

Drug: GSBR-1290Drug: Placebo

Part 2 (Cohort 2): GSBR-1290/Placebo Tablet

EXPERIMENTAL

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.

Drug: GSBR-1290Drug: Placebo

Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule

EXPERIMENTAL

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)Drug: Placebo (Capsule/Tablet)

Interventions

GSBR-1290 (Capsule/Tablet)DRUG

Participants will receive GSBR-1290 oral capsules or tablets.

Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 TabletPart 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 CapsulePart 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule
GSBR-1290DRUG

Participants will receive GSBR-1290 oral tablets.

Part 2 (Cohort 1): GSBR-1290/Placebo TabletPart 2 (Cohort 2): GSBR-1290/Placebo Tablet
PlaceboDRUG

Participants will receive matching-placebo oral tablets.

Part 2 (Cohort 1): GSBR-1290/Placebo TabletPart 2 (Cohort 2): GSBR-1290/Placebo Tablet
Placebo (Capsule/Tablet)DRUG

Participants will receive matching-placebo oral capsules or tablets.

Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ERG Clinical (Clinical Pharmacology of Miami - CPMI)

Miami, Florida, 33014, United States

Location

Syneos Miami Site

Miami, Florida, 33131, United States

Location

Parexel Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

CapsulesTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Part 1 is open-label, 2-period, 2-sequence, cross-over and Part 2 is double blinded
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

October 2, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Shared Documents
STUDY PROTOCOL
Time Frame
Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product have been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes: * re-evaluating safety and efficacy end points already addressed in the product labelling, * assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

Locations

US(3)