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

NCT04672499 | Completed Phase 1 FDA Drug

• 2 other identifiers: CORT118335-8532019-004655-36
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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)

Study Arms (6)

Cohort 1: Miricorilant 900 mg (Regimen A1)

EXPERIMENTAL

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

Cohort 1: Miricorilant 300 mg (Regimen A2)

EXPERIMENTAL

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

Cohort 2: Miricorilant (Regimen B1 and B2)

EXPERIMENTAL

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

Cohort 2: Placebo (Regimen B1 and B2)

PLACEBO COMPARATOR

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

Cohort 3: Miricorilant (Regimen C1 and C2)

EXPERIMENTAL

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

Cohort 3: Placebo (Regimen C1 and C2)

PLACEBO COMPARATOR

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

Interventions

Miricorilant 300 mg tablets DRUG

Miricorilant 300 mg tablets for oral administration

Also known as: CORT118335

Cohort 1: Miricorilant 900 mg (Regimen A1)

Miricorilant 150 mg tablets DRUG

Miricorilant 150 mg tablets for oral administration

Also known as: CORT118335

Cohort 1: Miricorilant 300 mg (Regimen A2); Cohort 2: Miricorilant (Regimen B1 and B2); Cohort 3: Miricorilant (Regimen C1 and C2)

Placebo 150 mg tablets DRUG

Placebo to match miricorilant 150 mg tablets for oral administration

Cohort 2: Placebo (Regimen B1 and B2); Cohort 3: Placebo (Regimen C1 and C2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of 18.0 to 30.0 kg/m\^2
• Must agree to adhere to the contraception requirements
• Additional criteria apply.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

CORT118335

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 17, 2020
• Study Start: April 27, 2020
• Primary Completion: September 7, 2020
• Study Completion: September 7, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)