Clinical trial NCT04672499: Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Miricorilant Tablet Formulations Following Single and Multiple Oral Doses in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants with One or More Adverse Events
timeFrame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
measure: Percentage of Participants with One or More Serious Adverse Events
timeFrame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
measure: Percentage of Participants Discontinued from the Study due to an Adverse Event
timeFrame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Secondary outcomes:
measure: Plasma Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)
timeFrame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
measure: Plasma PK of Miricorilant: Maximum Observed Concentration (Cmax)
timeFrame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
measure: Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax)
timeFrame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
measure: Plasma PK of Miricorilant: Apparent Elimination Half-life (t1/2)
timeFrame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
measure: Plasma PK of Miricorilant: Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-last)
timeFrame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
measure: Plasma PK of Miricorilant: Area Under the Curve from Time Zero to 24 Hours Postdose (AUC0-24)
timeFrame: Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Sharan Sidhu, MBChB, BAO, MRCS, MFPM
role: PRINCIPAL_INVESTIGATOR
References: