Food Effect of VS-6766 in Healthy Adult Subjects

Sponsor
Verastem, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05187169
Collaborator
(none)
18
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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

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 16, 2021
Actual Primary Completion Date :
Apr 12, 2022
Actual Study Completion Date :
Apr 12, 2022

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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

  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]

    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

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

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.
Responsible Party:
Verastem, Inc.
ClinicalTrials.gov Identifier:
NCT05187169
Other Study ID Numbers:
  • VS-6766-101
First Posted:
Jan 11, 2022
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 10, 2022