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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672499
• Other study ID #: CORT118335-853
• Secondary ID: 2019-004655-36
• Status: Completed
• Phase: Phase 1
• Start date: April 27, 2020
• Est. completion date: September 7, 2020

Study information

• Verified date: December 2020
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 7, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Miricorilant 300 mg tablets
Miricorilant 300 mg tablets for oral administration
• Miricorilant 150 mg tablets
Miricorilant 150 mg tablets for oral administration
• Placebo 150 mg tablets
Placebo to match miricorilant 150 mg tablets for oral administration

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)