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A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05893043
Recruitment Status : Completed
First Posted : June 7, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Gasherbrum Bio, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GSBR-1290 Other: Placebo Phase 1

Detailed Description:
This is a multiple ascending dose (MAD) study in which 4 dose levels will be evaluated in 2 cohorts from Day 1 to Day 28 (4-week period). The starting dose of GSBR-1290 will be based on results from the single ascending dose (SAD) study (GSBR-1290-01) and MAD study (GSBR-1290-02 [NCT05762471]).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Volunteers
Actual Study Start Date : April 24, 2023
Actual Primary Completion Date : June 28, 2023
Actual Study Completion Date : June 28, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: GSBR-1290 or Placebo
Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.
 Drug: GSBR-1290
Participants will receive GSBR-1290 oral capsules.
Other Name: GSBR-1001290

Other: Placebo
Participants will receive matching placebo oral capsules.
Experimental: Cohort 2: GSBR-1290
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
Participants will receive GSBR-1290 oral capsules.
Other Name: GSBR-1001290


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: From start of study drug up to End of study (EOS) (up to Day 42) ]
  2. Number of Participants Based on Severity of AEs [ Time Frame: From start of study drug up to EOS (up to Day 42) ]
  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to EOS (Day 42) ]
  4. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline up to EOS (Day 42) ]
  5. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [ Time Frame: Baseline up to EOS (Day 42) ]

Secondary Outcome Measures :
  1. Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters [ Time Frame: 31 days ]
  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 [ Time Frame: 31 days ]
  3. Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: 31 days ]
  4. 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 [ Time Frame: 31 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Cohort 1 only:

  1. Japanese participants must have both parents and 4 grandparents of Japanese origin

    For Cohort 2 only:

  2. 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:

  3. Must have given written informed consent before any study-related activities are carried out
  4. Adult males and females, age 18 to 55 years of age (inclusive) at screening
  5. 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
  6. No nicotine use
  7. 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
  8. Have suitable venous access for blood sampling

Exclusion Criteria:

  1. 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
  2. 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
  3. Estimated glomerular filtration rate (eGFR) < 60 milliliter per minute (mL/min)/1.73m^2 body surface area
  4. Known hypersensitivity to any of the study drug ingredients
  5. Any other condition or prior therapy that would make the participant unsuitable for this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05893043


Locations
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United States, California
ACT
Anaheim, California, United States, 92801
Sponsors and Collaborators
Gasherbrum Bio, Inc
More Information
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Responsible Party: Gasherbrum Bio, Inc
ClinicalTrials.gov Identifier: NCT05893043    
Other Study ID Numbers: GSBR-1290-03
First Posted: June 7, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No