A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects

An Open-Label, Repeat-Dose Study to Evaluate the Pharmacokinetics of Orally Administered CORT125134 Using the Current Capsule Formulation in Healthy Subjects

A study designed to characterize the plasma pharmacokinetic (PK) profile of CORT125134 in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134 for 14 days.

Initially, subjects will be enrolled into 2 cohorts each of 8 subjects (Cohort 1 and Cohort 2) to receive CORT125134 at 150 mg or 250 mg, respectively. Data from Cohorts 1 and 2 will be evaluated to select dose levels for Cohort 3 and optional Cohort 4.

The secondary objective of the study is to characterize the plasma PK profile of CORT125134 metabolites in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134.

Inclusion Criteria:

• Give written informed consent
• Be healthy males or non-pregnant, non-lactating healthy females
• Must agree to use an adequate method of contraception as described in the study protocol
• Have a body mass index (BMI) of 18 to 32 kg/m^2, inclusive and body weight more than 50 kg (110 pounds)
• Be willing to comply with study restrictions as described in study protocol
• Be able to comply with the requirements of the entire study
• Be judged to be in good health, based on the results of medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory findings
• Have suitable veins for multiple venipuncture/cannulation

Exclusion Criteria:

• Be an employee or immediate family member of the Clinical Research Unit or Corcept
• Have been previously enrolled in this study
• Have multiple drug allergies, or be allergic to any of the components of study drug
• Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
• In the 1 year before study drug administration, have a history of drug or alcohol abuse
• In the 6 calendar months before study drug administration, on average: have smoked more than 5 cigarettes/day, consumed more than 14 units (female) or 21 units (male) of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor), consumed licorice or other glycyrrhetic acid derivatives regularly, in the judgement of the Investigator
• In the 2 calendar months before study drug administration, have donated/ lost blood or plasma in excess of 400 mL
• In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
• Have a positive test for alcohol or drugs of abuse at Screening or admission
• Have a positive test for exogenous glucocorticoids at Screening
• Have clinically-relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at Screening and/or before first dose
• Have any medical or social reasons for not participating in the study raised by their primary care physician
• Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
• Have taken any prohibited prior medication, as described in study protocol