Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Miricorilant Tablet Formulations Following Single and Multiple Oral Doses in Healthy Participants

This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Miricorilant 300 mg tablets; Drug: Miricorilant 150 mg tablets; Drug: Placebo 150 mg tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Miricorilant 900 mg (Regimen A1); Participants will receive a single oral dose of miricorilant 900 mg (3 X 300 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label.	Drug: Miricorilant 300 mg tablets; Miricorilant 300 mg tablets for oral administration; Other Names: CORT118335
Experimental: Cohort 1: Miricorilant 300 mg (Regimen A2); Participants will receive a single oral dose of miricorilant 300 mg (2 X 150 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label.	Drug: Miricorilant 150 mg tablets; Miricorilant 150 mg tablets for oral administration; Other Names: CORT118335
Experimental: Cohort 2: Miricorilant (Regimen B1 and B2); Participants will receive a single oral dose of miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded.	Drug: Miricorilant 150 mg tablets; Miricorilant 150 mg tablets for oral administration; Other Names: CORT118335
Placebo Comparator: Cohort 2: Placebo (Regimen B1 and B2); Participants will receive a single oral dose of placebo matching miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded.	Drug: Placebo 150 mg tablets; Placebo to match miricorilant 150 mg tablets for oral administration
Experimental: Cohort 3: Miricorilant (Regimen C1 and C2); Participants will receive two oral doses (morning and evening) of miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded.	Drug: Miricorilant 150 mg tablets; Miricorilant 150 mg tablets for oral administration; Other Names: CORT118335
Placebo Comparator: Cohort 3: Placebo (Regimen C1 and C2); Participants will receive two oral doses (morning and evening) of placebo matching miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and placebo matching miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded.	Drug: Placebo 150 mg tablets; Placebo to match miricorilant 150 mg tablets for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with One or More Adverse Events	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)
Percentage of Participants with One or More Serious Adverse Events	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)
Percentage of Participants Discontinued from the Study due to an Adverse Event	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 Outcome Measures

Outcome Measure	Time Frame
Plasma Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)	Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Maximum Observed Concentration (Cmax)	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)
Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax)	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)
Plasma PK of Miricorilant: Apparent Elimination Half-life (t1/2)	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)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-last)	Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to 24 Hours Postdose (AUC0-24)	Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Actual): September 7, 2020
• Study Completion (Actual): September 7, 2020

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Cortisone
• Other Study ID Numbers: CORT118335-853; 2019-004655-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes