NCT05893043

Brief Summary

The purpose of this study is to assess safety and tolerability of multiple oral doses of GSBR-1290 (capsule) in healthy adult Japanese participants compared to non-Japanese participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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

April 24, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

May 30, 2023

Last Update Submit

July 13, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • Number of Participants With Adverse Events (AEs) and Serious AEs

    From start of study drug up to End of study (EOS) (up to Day 42)

  • Number of Participants Based on Severity of AEs

    From start of study drug up to EOS (up to Day 42)

  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Baseline up to EOS (Day 42)

  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

    Baseline up to EOS (Day 42)

  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

    Baseline up to EOS (Day 42)

Secondary Outcomes (4)

  • Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters

    31 days

  • Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

    31 days

  • Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

    31 days

  • Analysis of Area Under the Plasma Concentration-time Curve (AUC) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

    31 days

Study Arms (2)

Cohort 1: GSBR-1290 or Placebo

EXPERIMENTAL

Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.

Drug: GSBR-1290Other: Placebo

Cohort 2: GSBR-1290

EXPERIMENTAL

Healthy non-Japanese participants (Caucasians or African Americans) will receive once daily doses of study drug (GSBR-1290 oral capsules) for up to 4 weeks.

Drug: GSBR-1290

Interventions

GSBR-1290DRUG

Participants will receive GSBR-1290 oral capsules.

Also known as: GSBR-1001290
Cohort 1: GSBR-1290 or PlaceboCohort 2: GSBR-1290
PlaceboOTHER

Participants will receive matching placebo oral capsules.

Cohort 1: GSBR-1290 or Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For Cohort 1 only:
  • Japanese participants must have both parents and 4 grandparents of Japanese origin
  • For Cohort 2 only:
  • Non-Japanese participants must not have parents and grandparents of Japanese origin. Non-Japanese participants will be limited to Caucasians of European and Latin American descent or African Americans
  • For Cohorts 1 and 2:
  • Must have given written informed consent before any study-related activities are carried out
  • Adult males and females, age 18 to 55 years of age (inclusive) at screening
  • Body Mass Index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 24.9 kilogram per square meter (kg/m\^2), with a body weight (to 1 decimal place) \>= 45.0 kg at screening
  • No nicotine use
  • Sitting blood pressure after resting for 5 minutes between 90 to 140 millimeter of mercury (mm Hg) systolic and 50 to 90 mm Hg diastolic and a heart rate between 40 to 100 beats per minute
  • Have suitable venous access for blood sampling

You may not qualify if:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months
  • Liver function test results elevated \> 2.0-fold the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate transaminase (AST) or alanine transaminase (ALT). Bilirubin above ULN
  • Estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute (mL/min)/1.73m\^2 body surface area
  • Known hypersensitivity to any of the study drug ingredients
  • Any other condition or prior therapy that would make the participant unsuitable for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACT

Anaheim, California, 92801, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Study drug (GSBR-1290 or placebo) administration in Cohort 1 is double-blind and Study drug (GSBR-1290) administration in Cohort 2 is open label.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 7, 2023

Study Start

April 24, 2023

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

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(1)