CClinicalTrials.gg
CompletedNCT05712265Updated Mar 22, 2023

Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant

A Phase 1 interventional study of Miricorilant and Fluvoxamine in Antipsychotic Induced Weight Gain and Non-alcoholic Steatohepatitis (NASH), sponsored by Corcept Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by Corcept Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2023, 3 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Antipsychotic Induced Weight Gain
  • Non-alcoholic Steatohepatitis (NASH)
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 26 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • 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.

    Drug: Miricorilant · Drug: Fluvoxamine

Interventions

  • DrugMiricorilant

    Miricorilant 6 x 100 mg coated tablets

    Also known as: CORT118335

  • DrugFluvoxamine

    Fluvoxamine 50 mg tablet

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Number of participants with one or more treatment-emergent adverse events (TEAEs)

    Time frame: Up to 30 days after study drug administration

  2. Number of participants with one or more serious adverse events (SAEs)

    Time frame: Up to 30 days after study drug administration

  3. Number of participants with a clinically-significant vital sign abnormality

    Time frame: Up to Day 13

  4. Number of participants with a clinically-significant laboratory test abnormality

    Time frame: Up to Day 13

07

Study locations

1 site
  • Site 01
    Miami, Florida 33126, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05712265
Lead sponsor
Corcept Therapeutics
Responsible party
Sponsor
First posted
Feb 3, 2023
Start date
Jan 24, 2023
Primary completion
Feb 23, 2023
Completion
Feb 23, 2023
Last update
Mar 22, 2023

Study contacts

Joseph Custodio, PhD
study director · Corcept Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion