Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy participants.

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

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Body mass index of 18.0 to 30.0 kg/m^2

• Weight of ≤102 kg

• Must agree to adhere to the contraception requirements

• Additional criteria apply.

Exclusion Criteria:

• Received any investigational medicinal product in a clinical research study within the 90 days

• History of any drug or alcohol abuse in the past 2 years

• Regular alcohol consumption

• Current smokers and those who have smoked within the last 6 months

• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months

• Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative pregnancy test at screening and admission)

• Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator

• Confirmed positive drugs of abuse test result

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

• Active renal and/or hepatic disease

• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, GI, neurological or psychiatric disorder, as judged by the Investigator

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

• History and/or symptoms of adrenal insufficiency

• History of clinically significant gastrointestinal disease

• Has a condition that could be aggravated by glucocorticoid antagonism

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

• Presence or history of clinically significant allergy requiring treatment

• Donation or loss of greater than 400 mL of blood or plasma within the previous 3 months

• Are taking, or have taken, any prescribed, over-the-counter drug (other than 4 g per day paracetamol), vitamins or herbal remedies within 14 days before the study (exceptions may apply on a case by case basis)

• Are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products

• Additional criteria apply.