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A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 2.
Study details:
This study will be divided into two sequential parts: Part 1 single ascending dose (SAD), and Part 2 multiple ascending dose (MAD) with the overall design. Part 1 will enroll a total of approximately 38 healthy participants in five cohorts at 5 milligram (mg), 15 mg, 30 mg, 60 mg and 90 mg dose levels. Each cohort will have 2 participants receiving placebo.
There is no restriction on the male-to female ratio. Part 2 will be conducted after confirming the safety and tolerability of the -\>30mg dose in Part 1 and will enroll a total of approximately 30 healthy postmenopausal female participants and provisionally consists of three cohorts at 15 mg, 30 mg and 60 mg dose levels. Each cohort will have 2 participants receiving placebo.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-02-27
Primary completion: 2024-12-17
Study completion finish: 2024-12-17
Study type
OTHER
Phase
PHASE1
Trial ID
NCT06204250
Intervention or treatment
DRUG: GS1-144
DRUG: Placebo
Conditions
- • Vasomotor Symptoms
- • Adult Healthy Volunteers
Find a site
Closest Location:
Linear Clinical Research
Research sites nearby
Select from list below to view details:
Linear Clinical Research
Perth, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part 1 Single Ascending Dose: Cohorts 1 to 5
| DRUG: GS1-144
|
EXPERIMENTAL: Part 2 Multiple Ascending Dose: Cohorts 1 to 3
| DRUG: GS1-144
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Part 1: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Number of participants with TEAEs and SAEs will be reported. | Up to Day 4 |
Part 2:Number of Participants With TEAEs and SAEs | Number of female post-menopausal participants with TEAEs and SAEs will be reported. | Up to Day 12 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Parts 1 and 2: AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144 | AUC0-t will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Parts 1 and 2: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144 | AUC0-infinity will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Parts 1 and 2: Cmax- Maximum Observed Plasma Concentration for GS1-144 | Cmax will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Parts 1 and 2: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144 | Tmax will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Parts 1 and 2: T1/2- Terminal Half-life for GS1-144 | T1/2 will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Parts 1 and 2: CL/F- Apparent Clearance for GS1-144 | CL/F will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Parts 1 and 2: Vd/F- Apparent Volume of Distribution for GS1-144 | Vd/F will be assessed and reported. | Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144 | Cmax at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144 | Cmin at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: Tmax,ss- Time of Cmax at Steady State for GS1-144 | Tmax at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: Cavg,ss- Average Concentration at Steady State for GS1-144 | Cavg at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144 | AUC0-T at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: CLss/F- CL for Bioavailability at Steady State for GS1-144 | CL/F at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2: T1/2,ss- Terminal Half-life at Steady State for GS1-144 | T1/2 at steady state will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose | Accumulation Ratio will be assessed and reported. | Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose |
Frequently Asked Questions
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