Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02876796 | Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects | PHASE1 | COMPLETED | 30 | — | — | Aug 1, 2015 | Oct 1, 2015 | Aug 24, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| GS-0976 | DRUG | Capsule(s) administered orally |
| Placebo | DRUG | Capsule(s) administered orally |
| 1-13C acetate | OTHER | 10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours |
| Fructose solution | OTHER | Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses |
Inclusion Criteria: * Overweight and/or obese, but otherwise healthy males * Weight ≥ 50.0 kg * Body Mass Index (BMI): 25.0 - 32.0 kg/m\^2, inclusive Exclusion Criteria: * Intolerance to or malabsorption of fructose * A history of clinically significant gastrointestinal disease and/or surgery, wh...