Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Syneos Health | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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 46 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 60 mg and 120mg dose levels. Each cohort will have 2 participants receiving placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Single Ascending Dose: Cohorts 1 to 6 | Experimental | Participants will receive GS1-144 5 mg, 15 mg, 30 mg, 60 mg , 90 mg and 120mg tablets once on Day 1 in their respective Cohort in Part 1. 2 participants will receive placebo in each cohort. |
|
| Part 2 Multiple Ascending Dose: Cohorts 1 to 4 | Experimental | tablets once on Day 1 in their respective Cohort in Part 2. 2 participants will receive placebo in each cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS1-144 | Drug | Oral tablets. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Perth | Western Australia | WA 6027 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo tablets. |
|
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 |