Food Effect of VS-6766 in Healthy Adult Subjects

Food Effect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187169
• Other study ID #: VS-6766-101
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2021
• Est. completion date: April 12, 2022

Study information

• Verified date: May 2022
• Source: Verastem, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Effect

Intervention

Drug:
• VS-6766
Dual RAF/MEK inhibitor

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Verastem, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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