Status:
COMPLETED
Food Effect of VS-6766 in Healthy Adult Subjects
Lead Sponsor:
Verastem, Inc.
Conditions:
Food Effect
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05187169
Start Date
December 16 2021
End Date
April 12 2022
Last Update
May 10 2022
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283