Status:
COMPLETED
Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 C...
Detailed Description
This is a 3-part, single-center study of single and multiple ascending doses of CORT125329 in healthy participants. Part 1 will be a double-blind, randomized, placebo-controlled assessment of single ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04672512
Start Date
October 23 2020
End Date
January 17 2022
Last Update
February 9 2022
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS