1. Non-alcoholic steatohepatitis (NASH) 2. Antipsychotic-induced weight gain (AIWG) Not Applicable
Conditions
Interventions
This is a non-randomised, open-label trial. This one-part, healthy subject drug-drug interaction study aims to assess the pharmacokinetics (PK, what the body does to the drug) of five approved markete
tolbutamide (500 mg tablet)
midazolam (2.5 mg oral solution)
dolutegravir (50 mg tablet)
and rosuvastatin (10 mg tablet) on two occasions (on the mornings of Day 1 and Day 10). On the mornings of Day 4 to Day 12, subjects will receive 400 mg of miricorilant, as 8 x 50 mg tablets. Subjects
Sponsors
Corcept Therapeutics (United States)
Eligibility
Sex/Gender
All
Inclusion 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
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 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 9.2. Supine heart rate (HR) at rest of 100 bpm at screening and pre-(first) dose 9.3. Blood pressure (BP) outside the following ranges: diastolic BP 40-90 mmHg; systolic BP 90-140 mmHg (subjects aged 18-45 years) and 90-160 mmHg (subjects aged >45 years) at screening or before the first dose of study medication (NIMPs or IMP). HR and BP can be retested twice in the supine position at intervals of approximately 5 minutes on a given day 10. Subjects who have received any IMP or NIMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer 11. Subjects who report having received miricorilant in the 6 months before the first dose of miricorilant in this study 12. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood 13. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies (other than up to 4 g of paracetamol per day in the 14 days before first NIMP administration). COVID-19 vaccines are accepted as concomitant medications 14. Subjects who are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within 12 calendar months before the first NIMP administration, or 90 days for inhaled glucocorticoids. Subjects who have received up to two single doses of a glucocorticoid in another study more than 90 days before the first dose of study medication will not be excluded from taking part in the study for this reason 15. Any contraindication to the use of repaglinide, tolbutamide, midazolam, dolutegravir, rosuvastatin as per the Summary of Product Characteristics (SMPC) fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters Cmax, AUC(0-last) and AUC(0-inf) comparing repaglinide, tolbutamide, midazolam, dolutegravir and rosuvastatin administered before and after multiple dose administration of miricorilant collected from days 1 to 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability information for all study products and procedures are assessed by: 1. Incidence of adverse events (AEs) measured by monitoring for adverse events from signing the informed consent form until the follow-up phone call (before day -1 to day 23) 2. Measurement of vital signs, electrocardiograms, laboratory safety tests and physical examinations at screening, and at intervals from admission until discharge (day -1 to day 13). | — |
Countries
England, United Kingdom
Contacts
Public ContactSharan Sidhu
Outcome results
None listed