A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects

This study is a phase 1, open-label study to assess the single dose pharmacokinetics of suspension and capsule formulations of SR419 and repeat dose pharmacokinetics of capsule formulation of SR419, and to assess the effect of a high-fat meal on the pharmacokinetics of SR419 in healthy subjects.The trial will consist of 3 cohorts. Cohort 1 and 2 will follow a single sequence, 3-period, 2-formulation, dosing in fasted or fed state design. Cohort 3 will be a repeated dose study of SR419 capsule in healthy subjects.

Inclusion criteria

• Healthy males or females who are 18 to 64 years of age inclusive, are eligible.
• Body weight > 50 kg (110 pounds) and body mass index (BMI) between 18 and 30 kg/m2.
• Male or female subjects must agree to use contraception methods.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion criteria

• Clinically significant history of central nervous system (CNS) disease.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities
• History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
• History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
• History of sensitivity to any of the components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
• History of asthma (excluding resolved childhood asthma), anaphylaxis or anaphylactoid reactions, severe allergic responses.
• History of hypercoagulable state or history of thrombosis.
• A positive Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus (HIV) antibody result.
• A positive urinary cotinine test or history of regular use of tobacco- or nicotine-containing products (more than 4 products per month within 6 months prior to screening) or unwilling to refrain from use of such products from Screening until completion of the final study visit.
• A positive drug/alcohol result.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of IMP until the Safety Follow-up visit.
• A positive pregnancy test result.
• Breast-feeding and/or lactating subject.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.