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This study is a single-center, randomized, open-label, three-period crossover design, the objective is to evaluate the pharmacokinetics and safety of VV116 tablets, which are orally administered to Chinese healthy volunteers after fasting, standard diet or high-fat diet.
12 healthy subjects will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.
Investigational product administration plan given below: 12 healthy subjects will be randomized to 3 groups, i.e., Group A, Group B, Group C, with 4 subjects in each group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. Wash-out period is 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VV116 after High-fat meal intake | Experimental | a single oral after High-fat meal intake |
|
| VV116 after Fasting+Standard diet | Experimental | a single oral after Fasting |
|
| VV116 after Standard meal intake | Experimental | a single oral after Standard meal intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV116 | Drug | VV116 oral tablets, 400mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate high-fat diet and standard diet's effect on Cmax of VV116 tablets | maximum observed plasma concentration | From time zero up to 48 hours post-dose following oral administration of VV116 |
| Evaluate high-fat diet and standard diet's effect on AUC0-t of VV116 tablets | area under the plasma concentration time curve from time zero to the last measurable concentration | From time zero up to 48 hours post-dose following oral administration of VV116 |
| Evaluate high-fat diet and standard diet's effect on AUC0-∞ of VV116 tablets | area under the plasma concentration-time curve from time zero to infinity | From time zero up to 48 hours post-dose following oral administration of VV116 |
| Evaluate high-fat diet and standard diet's effect on Tmax of VV116 tablets | time at which Cmax occurs | From time zero up to 48 hours post-dose following oral administration of VV116 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment emergent adverse event (TEAE) of clinical symptoms | The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations, , ophthalmology and, etc. | 7 days after last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gangyi Liu | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| C000722705 | GS-621763 |
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| The incidence and severity of treatment emergent adverse event (TEAE) of vital signs | The incidence and severity of treatment emergent adverse event (TEAE) of vital signs | 7 days after last treatment |
| The incidence and severity of treatment emergent adverse event (TEAE)of physical examinations | The incidence and severity of treatment emergent adverse event (TEAE)of physical examinations | 7 days after last treatment |
| The incidence and severity of treatment emergent adverse event (TEAE) of laboratory tests | The incidence and severity of treatment emergent adverse event (TEAE) of laboratory tests | 7 days after last treatment |
| The incidence and severity of treatment emergent adverse event (TEAE) of physical examinations | The incidence and severity of treatment emergent adverse event (TEAE) of physical examinations | 7 days after last treatment |
| The incidence and severity of treatment emergent adverse event (TEAE) of electrocardiogram (ECG) | The incidence and severity of treatment emergent adverse event (TEAE) of electrocardiogram (ECG) | 7 days after last treatment |