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The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM).
The primary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Single-ascending Dose (SAD) in Healthy Participants | Experimental | Participants will be randomized into 4 + (optional) 1 dose escalating cohorts and will receive GS-4571 or placebo to match (PTM) GS-4571 on Day 1, to determine the maximum tolerated dose:
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| Part B Food/PPI Effect in Healthy Participants | Experimental | Participants will be randomized into 2 sequence groups in Cohort 6 and will receive the highest dose found to be safe and well tolerated in Part A of GS-4571 and omeprazole. The two sequential groups will receive the following treatments:
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| Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese Participants | Experimental | Participants randomized in Cohorts 7-9 will be randomized to receive up to 4 escalating doses of GS-4571 or PTM QD for 12 weeks, as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-4571 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Single-Dose PK Parameter AUCinf of GS-4571 | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time. | Up to 96 hours postdose |
| Single-Dose PK Parameter Cmax of GS-4571 | Cmax is defined as the maximum observed concentration of drug in plasma. | Up to 96 hours postdose |
| Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571 | AUCtau is defined as area under the concentration versus time curve over the dosing interval. | Up to 96 hours postdose |
| Multiple-Dose Plasma PK Parameter: Cmax of GS-4571 | Cmax is defined as the maximum observed concentration of drug in plasma. | Up to 96 hours postdose |
| Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths | Day 1 up to 95 days | |
| Percentage of Participants of Treatment-Emergent Laboratory Abnormalities | Day 1 up to 95 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants | Day 1 up to 95 days |
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Key Inclusion Criteria:
Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc. | Recruiting | Miami | Florida | 33143 | United States | |
| ICON Early Phase Services, LLC |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Part D Multiple Dose in Nonobese Participants With T2DM | Experimental | Participants randomized in Cohort 11 will receive up to the highest dose of GS-4571 or PTM in T2DM, QD, in a non-fasting state for 12 weeks. |
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| Placebo | Drug | Administered orally |
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| Omeprazole | Drug | Administered orally |
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| Recruiting |
| San Antonio |
| Texas |
| 78232 |
| United States |
| ICON | Recruiting | Salt Lake City | Utah | 84124 | United States |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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