Food Effect of VS-6766 in Healthy Adult Subjects
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Treatment A 4.0 mg VS-6766, following an overnight fast of at least 10 hours |
Drug: VS-6766
Dual RAF/MEK inhibitor
|
Active Comparator: Treatment B 4.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast |
Drug: VS-6766
Dual RAF/MEK inhibitor
|
Outcome Measures
Primary Outcome Measures
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-t [30 days]
Area under plasma Concentration (AUC) 0 to t
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-120 [30 days]
Area under plasma Concentration (AUC) from 0-120 minutes
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-inf [30 days]
Area under plasma Concentration (AUC) from zero to infinity
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC%extrap [30 days]
Area under plasma Concentration (AUC) extrapolated
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Cmax [30 days]
Cmax for VS-6766 administered with and without food.
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tlag [30 days]
absorption lag-time (Tlag)
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tmax [30 days]
time of Maximum concentration (Tmax)
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Kel [30 days]
Elimination rate (Kel)
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: T1/2 [30 days]
concentration Half-life (T1/2)
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: CL/F [30 days]
Oral Clearance (CL/F)
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Vz/F [30 days]
Apparent Volume of Distribution (Vz/F) for VS-6766 administered with and without food.
Secondary Outcome Measures
- 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. [30 days]
Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, lab parameters, vital signs, ECG and ophthalmologic changes
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age, inclusive, at the screening visit.
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Must follow protocol specified contraception guidance.
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Continuous non-smoker who has not used tobacco/nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
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Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
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Medically healthy with no clinically significant medical history.
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Able to swallow capsules.
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Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Exclusion Criteria:
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Presence of systemic or severe infection.
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History or presence of a significant medical condition or disease which is not completely resolved.
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History or presence of alcohol or drug abuse
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History or presence of hypersensitivity or reaction to the study drug or related compounds.
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History of tuberculosis.
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Presence of any fever within 2 weeks prior to first dosing.
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Females able to have children.
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Females who are pregnant or lactating.
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Presence of HIV.
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Must be able to refrain from using any drugs, including prescription and non-prescription medications beginning 28 days prior to the first dosing.
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Lactose Intolerance.
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Donation of blood or significant blood loss or blood transfusion within 56 days prior to the first dosing.
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Plasma donation within 7 days prior to the first dosing.
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Participation in another clinical study within 30 days prior to the first dosing.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Celerion | Tempe | Arizona | United States | 85283 |
Sponsors and Collaborators
- Verastem, Inc.
Investigators
- Study Director: Louis Denis, MD, Verastem, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VS-6766-101