Food Effect of VS-6766 in Healthy Adult Subjects

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.

Inclusion criteria

• 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 criteria

• 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.