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Completed

NCT Number: NCT05893043

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ACT

Anaheim, California, 92801, United States

About this study

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]).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

GSBR-1290

Drug

Participants will receive GSBR-1290 oral capsules.

Other names: GSBR-1001290

Placebo

Other

Participants will receive matching placebo oral capsules.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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