Food Effect of VS-6766 in Healthy Adult Subjects

Verastem

Status and phase: Completed; Phase 1

Conditions: Food Effect

Treatments: Drug: VS-6766

Study type: Interventional

Funder types: Industry

Identifiers

NCT05187169

VS-6766-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Treatment A

Active Comparator group

Description:

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

Treatment:

Drug: VS-6766

Treatment B

Active Comparator group

Description:

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

Treatment:

Drug: VS-6766