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An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in a 2-way crossover fashion either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose. There will be a washout period between doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | 4.0 mg VS-6766, following an overnight fast of at least 10 hours |
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| Treatment B | Active Comparator | 4.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS-6766 | Drug | Dual RAF/MEK inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-t | Area under plasma Concentration (AUC) 0 to t | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-120 | Area under plasma Concentration (AUC) from 0-120 minutes | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-inf | Area under plasma Concentration (AUC) from zero to infinity | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC%extrap | Area under plasma Concentration (AUC) extrapolated | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Cmax | Cmax for VS-6766 administered with and without food. | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tlag | absorption lag-time (Tlag) | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tmax |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of a single-dose of VS-6766 administered with or without a standardized high-fat/high-calorie meal in healthy adult subjects. | Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, lab parameters, vital signs, ECG and ophthalmologic changes | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Denis, MD | Verastem, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
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time of Maximum concentration (Tmax) |
| 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Kel | Elimination rate (Kel) | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: T1/2 | concentration Half-life (T1/2) | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: CL/F | Oral Clearance (CL/F) | 30 days |
| Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Vz/F | Apparent Volume of Distribution (Vz/F) for VS-6766 administered with and without food. | 30 days |