Levoketoconazole Food Effect Study in Healthy Subjects

In each period of the randomized, two period crossover study, levoketoconazole will be administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal). Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in Period 2.

Inclusion criteria

• Subject is 18-55 years of age, inclusive, at time of consent.
• Subject has a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
• Subject is in good general physical health as determined by absence of clinically significant medical history, physical examination findings, vital signs, clinical laboratory evaluations, and ECG measurements.
• Subject has not consumed and agrees to abstain from taking any prescription drugs, dietary supplements including vitamins and herbal preparations, or non-prescription drugs (except as authorized by the Investigator AND Medical Monitor) for 14 days prior to CRU admission, during washout period, and through Follow-Up.
• Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up.
• Subject is a nonsmoker (for at least 3 months) with negative urinary cotinine test at Screening and agrees to abstain from tobacco- and nicotine-containing products for the duration of the study.

Exclusion criteria

• Evidence of any out-of-normal-range laboratory value at Screening that has not been reviewed, approved, and documented as Not Clinically Significant by the Investigator.
• Concurrent medical illness that would interfere with the conduct of the study in the opinion of the Investigator.
• History or presence of clinically significant cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease as judged by the Investigator.
• Positive urine drug screen for drugs-of-abuse, including cocaine, tetrahydrocannabinol, opioids, benzodiazepines, amphetamines, and barbiturates, and/or positive urine screen for alcohol at Screening and CRU admission.
• Treatment with an investigational drug within the longer of 30 days or five half-lives of the investigational drug preceding the first dose of study drug.
• Subject is positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or hepatitis C on Screening assessments.
• Subject has an acute illness within 7 days of CRU admission.
• Subject has donated plasma within 7 days of drug administration.
• Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to drug administration.
• History of caffeine consumption exceeding 8 cups of coffee/day (1 cup = 8 fluid ounces) within 14 days prior to first dose, or consumption of any caffeine- or chocolate-containing products for 3 days prior to CRU admission each week. Caffeine-containing foods and/or beverages (e.g., tea and cola) should be considered equivalent to coffee.
• Female subjects who are pregnant or lactating.
• Males with hemoglobin less than 12.0 g/dL; Females with hemoglobin less than 11.0 g/dL.
• Subjects who have had difficulties with swallowing whole tablets.
• Subjects with body habitus preventing repeated venipuncture as required by protocol.