Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

• Status: Completed
• Trial end date: 2020-10-04
• Target enrollment: 0
• Participant gender: All

Summary

This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Cortisone; Prednisone

Criteria

Inclusion Criteria:

• Body mass index (BMI) 18.0 to 30.0 kg/m^2, inclusive

• Body weight ≤102 kg

• Willing to consume a high-fat breakfast, including pork

• Agrees to adhere to the contraception requirements of the protocol

• Additional criteria apply.

Exclusion Criteria:

• Received any investigational drug or device in a clinical research study within the last 90 days

• History of any drug or alcohol abuse in the last 2 years; a confirmed positive drugs of abuse test result

• Regular alcohol consumption; a confirmed positive alcohol breath test at screening

• Current smoker; a confirmed positive breath carbon monoxide reading; current user of e-cigarettes or nicotine replacement products in the last 6 months

• Female of childbearing potential, pregnant or breastfeeding

• Have a pregnant partner

• Clinically significant abnormal clinical chemistry, hematology, or urinalysis result

• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV)

• Active renal or hepatic disease

• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal, neurological, or psychiatric disorder

• Any form of cancer in the last 5 years (exceptions apply)

• History of adrenal insufficiency

• Have a condition that could be aggravated by glucocorticoid and/or mineralocorticoid blockade

• Currently using glucocorticoids or a history of systemic glucocorticoid use in the last 12 months or 3 months for inhaled products

• Additional criteria apply.