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| Name | Class |
|---|---|
| Nimbus Apollo | INDUSTRY |
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The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976 (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose administration in overweight and/or obese, but otherwise healthy, male adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg GS-0976 (Cohort 1) | Experimental | Sequence 1: Period 1 (2 days): 50 mg (1 x 50 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 2: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 50 mg (1 x 50 mg capsule) + IV infusion 1-13C acetate and fructose solution |
|
| 200 mg GS-0976 (Cohort 2) | Experimental | Sequence 3: Period 1 (2 days): 200 mg (1 x 200 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 4: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 200 mg (1 x 200 mg capsule) + IV infusion 1-13C acetate and fructose solution |
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| 20 mg GS-0976 (Cohort 3) | Experimental | Sequence 5: Period 1 (2 days): 20 mg (2 X 10 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 6: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 20 mg (2 X 10 mg capsule) + IV infusion 1-13C acetate and fructose solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-0976 | Drug | Capsule(s) administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fractional DNL (% new palmitate) | Predose and up to 10 hours postdose | |
| Change in DNL over time following administration of GS-0976 and placebo | Predose and up to 10 hours postdose | |
| Change from baseline over time in adiponectin | Baseline and up to 10 hours postdose | |
| Percent change from baseline over time in adiponectin | Baseline and up to 10 hours postdose | |
| Change from baseline over time in leptin | Baseline and up to 10 hours postdose | |
| Percent change from baseline over time in leptin | Baseline and up to 10 hours postdose | |
| Change from baseline over time in blood ketones | Baseline and up to 10 hours postdose | |
| Percent change from baseline over time in blood ketones | Baseline and up to 10 hours postdose | |
| Change from baseline over time in lipid profile | Baseline and up to 10 hours postdose | |
| Percent change from baseline over time in lipid profile | Baseline and up to 10 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of GS-0976 and placebo | Up to 42 days | |
| Percentage of participants experiencing abnormal clinical laboratory tests | Up to 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob Myers, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States |
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| Placebo | Drug | Capsule(s) administered orally |
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| 1-13C acetate | Other | 10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours |
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| Fructose solution | Other | Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses |
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| Pharmacokinetics (PK) of GS-0976 and its metabolite: tmax | Tmax is defined as the time (observed time point) of Cmax. | Baseline and up to 10 hours postdose |
| PK of GS-0976 and its metabolite: Cmax | Cmax is defined as the maximum concentration of drug. | Baseline and up to 10 hours postdose |
| PK of GS-0976 and its metabolite: AUC_0-t | AUC_0-t is defined as the concentration of drug over time from time zero to time "t". | Baseline and up to 10 hours postdose |
| ID | Term |
|---|---|
| C000629250 | firsocostat |
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