Food Effect of VS-6766 in Healthy Adult Subjects

NCT05187169 | Completed Phase 1 FDA Drug

• 1 other identifier: VS-6766-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Food Effect

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (1)

• 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

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

4.0 mg VS-6766, following an overnight fast of at least 10 hours

Drug: VS-6766

Treatment B

ACTIVE COMPARATOR

4.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast

Drug: VS-6766

Interventions

VS-6766 DRUG

Dual RAF/MEK inhibitor

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Verastem, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Louis Denis, MD

  Verastem, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: December 16, 2021
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (1)