Food Effect of VS-6766 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Food Effect
• Interventions: Drug: VS-6766

• Registration Number: NCT05187169
• Lead Sponsor: Verastem, Inc.

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

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 Timeline

• Study Start: 2021-12-16
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2022-01-11
• Primary Completion: 2022-04-12
• Study Completion: 2022-04-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	VS-6766	4.0 mg VS-6766, following an overnight fast of at least 10 hours
Treatment B	VS-6766	4.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast

Primary Outcome Measures

Name	Time	Method
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-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: 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: Vz/F	30 days	Apparent Volume of Distribution (Vz/F) 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: 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: 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: 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: Tmax	30 days	time of Maximum concentration (Tmax)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States