ISRCTN10379288
Active, Not Recruiting
Phase 1
An open-label, drug-drug interaction study designed to evaluate the potential effect of miricorilant on cytochrome P450 2C8, 2C9, 3A4, uridine-diphospho-glucuronosyltransferase 1A1 enzyme activity, and breast cancer resistance protein activity using probe substrates in healthy male and female subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 1. Non-alcoholic steatohepatitis (NASH)2. Antipsychotic-induced weight gain (AIWG)
- Sponsor
- Corcept Therapeutics (United States)
- Enrollment
- 30
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provide written informed consent
- •2\. Willing and able to communicate and participate in the whole study
- •3\. Aged 18 to 60 years inclusive at the time of signing the informed consent
- •4\. Agree to adhere to the contraception requirements defined in the clinical protocol
- •5\. Male subjects or non\-pregnant, non\-lactating female subjects of non\-childbearing potential
- •6\. Participants who are healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12\-lead ECGs, screening clinical laboratory profiles (haematology, clinical chemistry, and urinalysis), as deemed by the Investigator or designee
- •7\. Body mass index (BMI) of 19\.0 to 32\.0 kg/m2 as measured at screening
- •8\. Body weight \=50 kg at screening
Exclusion Criteria
- •1\. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2\. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active
- •3\. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease (including cholecystectomy), bleeding disorder, neurological or psychiatric disorder, as judged by the Investigator.
- •4\. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening
- •5\. Clinically significant abnormal clinical chemistry (including AST and/or ALT \>1\.5 × the upper limit of the reference range or CK \>1\.5 × ULN), haematology or urinalysis as judged by the Investigator (laboratory parameters are listed in the clinical protocol). Subjects with Gilbert’s Syndrome are allowed
- •6\. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or (HIV) 1 and 2 antibody results
- •7\. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of \<80 mL/min/1\.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD\-EPI; 2009\) equation
- •8\. Female subjects of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive serum (at screening) or urine (at admission) pregnancy test)
- •9\. Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline (pre\-first dose) including but not limited to:
- •9\.1\. QTcF \> 450 msec based on a single ECG at screening, and based on the mean of 3 supine ECGs performed at least 2 minutes apart at Day 1 pre\-dose
Outcomes
Primary Outcomes
Not specified
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