Status:
COMPLETED
Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.
Detailed Description
Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label. Optional Coh...
Eligibility Criteria
Inclusion
- Body mass index (BMI) of 18.0 to 30.0 kg/m\^2
- Must agree to adhere to the contraception requirements
- Additional criteria apply.
Exclusion
- Received any investigational medicinal product in a clinical research study within the last 90 days
- Male participants who have pregnant or lactating partners
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption: a confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked or used e-cigarettes or nicotine replacement products within the last 6 months
- Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at 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, chronic respiratory, neurological or psychiatric disorder, as judged by the Investigator
- Any form of cancer within the last 2 years (exceptions apply)
- History and/or symptoms of adrenal insufficiency
- Regularly consumes liquorice or other glycyrrhetic acid derivatives
- History of clinically significant gastrointestinal disease
- Currently using glucocorticoids or have a history of systemic glucocorticoid use within the last 12 months or 3 months for inhaled products
- Presence or history of clinically significant allergy requiring treatment
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Taking, or have taken, any prescribed, over-the-counter drug (other than up to 4 g per day paracetamol) or vitamins/herbal remedies within 14 days. Exceptions may apply on a case by case basis
- Additional criteria apply.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04672499
Start Date
April 27 2020
End Date
September 7 2020
Last Update
December 17 2020
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS