Food Effect of VS-6766 in Healthy Adult Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Food Effect
• Intervention / Treatment: Drug: VS-6766

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age, inclusive, at the screening visit.
2. Must follow protocol specified contraception guidance.
3. 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.
4. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
5. Medically healthy with no clinically significant medical history.
6. Able to swallow capsules.
7. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Presence of systemic or severe infection.
2. History or presence of a significant medical condition or disease which is not completely resolved.
3. History or presence of alcohol or drug abuse
4. History or presence of hypersensitivity or reaction to the study drug or related compounds.
5. History of tuberculosis.
6. Presence of any fever within 2 weeks prior to first dosing.
7. Females able to have children.
8. Females who are pregnant or lactating.
9. Presence of HIV.
10. Must be able to refrain from using any drugs, including prescription and non-prescription medications beginning 28 days prior to the first dosing.
11. Lactose Intolerance.
12. Donation of blood or significant blood loss or blood transfusion within 56 days prior to the first dosing.
13. Plasma donation within 7 days prior to the first dosing.
14. Participation in another clinical study within 30 days prior to the first dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Verastem, Inc.
• Investigators: Study Director: Louis Denis, MD, Verastem, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): April 12, 2022

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VS-6766-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No