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Healthy VolunteersPhase 1NCT06139055

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

A Phase 1 study testing GSBR-1290 (Capsule/Tablet) and GSBR-1290 in people with Healthy Volunteers, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
GSBR-1290 (Capsule/Tablet) and GSBR-1290
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
3 sitesUnited States
Study dates
2 Oct 2023to Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Parexel Baltimore Early Phase Clinical Unit

    Baltimore, Maryland, 21225

  • ERG Clinical (Clinical Pharmacology of Miami - CPMI)

    Miami, Florida, 33014

  • Syneos Miami Site

    Miami, Florida, 33131

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
GSBR-1290 (Capsule/Tablet), GSBR-1290, Placebo, Placebo (Capsule/Tablet)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSBR-1290 (Capsule/Tablet)Drug

    Participants will receive GSBR-1290 oral capsules or tablets.

  • GSBR-1290Drug

    Participants will receive GSBR-1290 oral tablets.

  • PlaceboDrug

    Participants will receive matching-placebo oral tablets.

  • Placebo (Capsule/Tablet)Drug

    Participants will receive matching-placebo oral capsules or tablets.

Study groups in NCT06139055
Study groupRoleWhat they receive
Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 TabletExperimentalParticipants 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).
Receives: Drug: GSBR-1290 (Capsule/Tablet)
Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 CapsuleExperimentalParticipants 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).
Receives: Drug: GSBR-1290 (Capsule/Tablet)
Part 2 (Cohort 1): GSBR-1290/Placebo TabletExperimentalParticipants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.
Receives: Drug: GSBR-1290; Drug: Placebo
Part 2 (Cohort 2): GSBR-1290/Placebo TabletExperimentalParticipants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.
Receives: Drug: GSBR-1290; Drug: Placebo
Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo CapsuleExperimentalParticipants 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.
Receives: Drug: GSBR-1290 (Capsule/Tablet); Drug: Placebo (Capsule/Tablet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From start of study drug up to Day 10

  2. 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

    Measured: From start of study drug up to Day 10

  3. 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

    Measured: From start of study drug up to Day 10

  4. 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

    Measured: From start of study drug up to Day 10

  5. 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

    Measured: From start of study drug up to Day 10

  6. 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

    Measured: From start of study drug up to Day 10

  7. 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

    Measured: From start of study drug up to Day 10

  8. Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs

    Measured: From start of study drug up to End of study (EOS) in Part 2 (up to Day 98)

  9. Part 2: Number of Participants With Severity of AEs

    Measured: From start of study drug up to EOS in Part 2 (up to Day 98)

  10. Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: From start of study drug up to EOS in Part 2 (up to Day 98)

  11. Part 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

    Measured: From start of study drug up to EOS in Part 2 (up to Day 98)

  12. Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

    Measured: From start of study drug up to EOS in Part 2 (up to Day 98)

Secondary outcomes (10)

  1. Part 1: Number of Participants With Adverse Events (AEs) and Serious AEs

    Measured: From start of study drug up to EOS in Part 1 (Day 17)

  2. Part 1: Number of Participants Based on Severity of AEs

    Measured: From start of study drug up to EOS in Part 1 (Day 17)

  3. Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: Baseline up to EOS in Part 1 (Day 17)

  4. Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

    Measured: Baseline up to EOS in Part 1 (Day 17)

  5. Part 1: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

    Measured: Baseline up to EOS in Part 1 (Day 17)

  6. 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

    Measured: From start of study drug up to Day 84

  7. 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

    Measured: From start of study drug up to Day 84

  8. 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

    Measured: From start of study drug up to Day 84

  9. Part 2: Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

    Measured: From start of study drug up to Day 84

  10. 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

    Measured: From start of study drug up to Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start2 Oct 2023
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139055
Sponsor's protocol ID
GSBR-1290-05
Status last verified
Feb 2024
First submitted
14 Nov 2023
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSBR-1290 (Capsule/Tablet) and GSBR-1290 in people with Healthy Volunteers, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From start of study drug up to Day 10). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06139055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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