- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712265
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
March 20, 2023 updated by: Corcept Therapeutics
A Phase 1, Open-Label, Fixed-Sequence Crossover Study to Evaluate the Effect of a Strong Inhibitor of Cytochrome P450 2C19 on the Pharmacokinetics of Miricorilant in Healthy Subjects
The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 [(CYP) 2C19] inhibitor, fluvoxamine, in healthy participants.
Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine.
Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33126
- Site 01
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to understand a written informed consent
- Willing and able to comply with all study requirements including potential CYP 2C19 genotyping analysis
- Male participants must agree to use an adequate method of contraception
- Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential
- Body mass index of 19.0 to 32.0 kg/m^2
- Body weight ≥50 kg.
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active.
- Significant skin disease, including rash, food allergy, eczema, psoriasis, or urticaria
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), bleeding disorder, neurological or psychiatric disorder, as judged by the Investigator
- Poor venous access that limits phlebotomy
- Evidence of current SARS-CoV-2 infection
- Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are allowed.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- Evidence of renal impairment at screening
- Positive highly sensitive serum pregnancy test at screening or admission. Those who are pregnant or lactating will be excluded. A woman is considered of childbearing potential unless she is permanently sterile or is postmenopausal.
- Clinically-significant ECG abnormalities or vital sign abnormalities at screening or at baseline
- Have received any study drug in a clinical research study within 30 days (or 5 half-lives if longer) prior to first dose of study medication
- Are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 2 g per day acetaminophen or COVID-19 vaccines) in the 14 days before study drug administration. Exceptions may apply.
- Are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months, or 3 months for inhaled products
- Are taking, or have taken, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors within 3 months before study drug administration
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in men >21 units per week and women >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
- Confirmed positive alcohol urine test at screening or admission
- Current smokers and those who have smoked within the last 12 months
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Positive drugs of abuse test result
- Male participants with pregnant or lactating partners
- Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication
- Are, or are immediate family members of a study site or Sponsor employee
- Failure to satisfy the investigator of fitness to participate for any other reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Miricorilant - Fluvoxamine/Miricorilant
Participants will receive a single oral dose of miricorilant 600 mg on Days 1 and 10 and a single oral dose of fluvoxamine 50 mg on Days 4 to 12.
|
Miricorilant 6 x 100 mg coated tablets
Other Names:
Fluvoxamine 50 mg tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration of miricorilant (Cmax)
Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
|
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
|
Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last)
Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
|
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
|
Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf)
Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
|
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with one or more treatment-emergent adverse events (TEAEs)
Time Frame: Up to 30 days after study drug administration
|
Up to 30 days after study drug administration
|
Number of participants with one or more serious adverse events (SAEs)
Time Frame: Up to 30 days after study drug administration
|
Up to 30 days after study drug administration
|
Number of participants with a clinically-significant vital sign abnormality
Time Frame: Up to Day 13
|
Up to Day 13
|
Number of participants with a clinically-significant laboratory test abnormality
Time Frame: Up to Day 13
|
Up to Day 13
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2023
Primary Completion (Actual)
February 23, 2023
Study Completion (Actual)
February 23, 2023
Study Registration Dates
First Submitted
January 25, 2023
First Submitted That Met QC Criteria
January 25, 2023
First Posted (Actual)
February 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 20, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Diseases
- Body Weight
- Body Weight Changes
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
- Weight Gain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Anti-Anxiety Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluvoxamine
Other Study ID Numbers
- CORT118335-856
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.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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