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HealthyPhase 1NCT07240116

Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects

A Phase 1 study testing Miricorilant Treatment A, Miricorilant Treatment B and Miricorilant Treatment C in people with Healthy, run by Corcept Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Miricorilant Treatment A, Miricorilant Treatment B and Miricorilant Treatment C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
11 Sep 2025to 3 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to understand written informed consent
  • Willing and able to comply with study requirements
  • Willing to comply with protocol-specified contraception requirements
  • Healthy male or non-pregnant, non-lactating female of non-childbearing potential per Investigator assessment.
  • Body mass index (BMI) of 18.0 to 30.0 kg/m^2 at screening
  • Weight of at least 50 kg at screening

Who cannot join

  • Serious adverse reaction or hypersensitivity to any drug or formulation excipients
  • History of clinically significant allergy requiring treatment
  • History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
  • Any form of cancer within the 5 years before the first does of this study
  • History and/or symptoms of adrenal insufficiency
  • History of clinically significant GI disease
Show all 29Show fewer
  • Condition or history of a condition that could be aggravated by glucocorticoid antagonism or glucocorticoid activation
  • History of additional risk factors for torsades de pointes
  • Poor venous access that limits phlebotomy
  • Clinically significant abnormal clinical chemistry, hematology or urinalysis
  • History or evidence of hypokalemia
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
  • Evidence of renal impairment at screening
  • Positive serum or highly sensitive urine pregnancy test at screening or first admission
  • Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline
  • Received any investigational medicinal products (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose
  • Donation of blood within 2 months or donation of plasma within 1 week prior to first dose of study medication
  • Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies in the 14 days before first IMP administration
  • Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months before first IMP administration or 3 months for inhaled products
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption as defined in the study protocol
  • A confirmed positive alcohol urine test at screening or first 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
  • A confirmed positive urine cotinine test at screening or first admission
  • Positive drug screen test result at screening or first admission
  • Male subjects with pregnant or lactating partners
  • Study site or Sponsor employee or immediate family members one
  • Failure to satisfy the Investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Site 01

    Miami, Florida, 33126

Other trials in United States

About this study

Official title: An Open-Label, Randomized, 3-Treatment, 3-Period, 6-Sequence, Balanced Crossover Study to Characterize the Relative Bioavailability of Miricorilant Administered as 50-mg and 100-mg Kinetisol Tablets vs the 50-mg Spray Dried Dispersion Tablet Formulation With an Optional Food Effect Assessment in Healthy Adult Subjects

This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.

Read the detailed description

This study will evaluate relative bioavailability of Kinetisol and spray dried dispersion (SDD) miricorilant (CORT118335) tablets. This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess the impact of fasted conditions.

Conditions
Healthy
Being tested
Miricorilant Treatment A, Miricorilant Treatment B, Miricorilant Treatment C, Miricorilant Treatment D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Miricorilant Treatment ADrug

    Also called CORT118335

    Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

  • Miricorilant Treatment BDrug

    Also called CORT118335

    Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

  • Miricorilant Treatment CDrug

    Also called CORT118335

    Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

  • Miricorilant Treatment DDrug

    Also called CORT118335

    Miricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete.

Study groups in NCT07240116
Study groupRoleWhat they receive
Miricorilant Treatment Sequence A, B, CExperimentalParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
Receives: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C
Miricorilant Treatment Sequence B, C, AExperimentalParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
Receives: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C
Miricorilant Treatment Sequence C, A, BExperimentalParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
Receives: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C
Miricorilant Treatment Sequence B, A, CExperimentalParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
Receives: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C
Miricorilant Treatment Sequence A, C, BExperimentalParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
Receives: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C
Miricorilant Treatment Sequence C, B, AExperimentalParticipants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
Receives: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C
Optional Miricorilant Treatment DExperimentalAfter completion of Period 3, analysis of pharmacokinetic and safety data will be used to decide if Period 4 will be conducted. In Period 4, selected participants will receive a single dose of treatment D in a fasted state on Day 1.
Receives: Drug: Miricorilant Treatment D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of Maximum Observed Concentration (Tmax) of Miricorilant

    Measured: Predose and at serial timepoints up to 72 hours postdose

  2. Maximum Observed Concentration (Cmax) of Miricorilant

    Measured: Predose and at serial timepoints up to 72 hours postdose

  3. Concentration at 24 Hours Postdose (C24) of Miricorilant

    Measured: Predose and at serial timepoints up to 24 hours postdose

  4. Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant

    Measured: Predose and at serial timepoints up to 72 hours postdose

  5. Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant

    Measured: Predose and at serial timepoints up to 72 hours postdose

  6. Terminal Elimination Half-Life (T1/2) of Miricorilant

    Measured: Predose and at serial timepoints up to 72 hours postdose

  7. Relative Bioavailability (Frel) for Miricorilant Based on Cmax

    Measured: Predose and at serial timepoints up to 72 hours postdose

  8. Frel for Miricorilant based on AUC(0-last)

    Measured: Predose and at serial timepoints up to 72 hours postdose

  9. Frel for Miricorilant Based on AUC(0-inf)

    Measured: Predose and at serial timepoints up to 72 hours postdose

Secondary outcomes (5)

  1. Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings

    Clinical laboratory findings include hematology, clinical chemistry, urinalysis.

    Measured: Day -1 and 72 hours postdose in periods 3 and 4

  2. Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings

    Measured: Day -1, predose, and at 4 and 72 hours postdose in every study period

  3. Number of Participants with Abnormal, Clinically Significant Vital Sign Findings

    Measured: Day -1, predose, and at serial time points up to 72 hours postdose in every study period

  4. Number of Participants with Abnormal, Clinically Significant Physical Exam Findings

    Measured: 72 hours postdose in periods 3 and 4

  5. Number of Participants with 1 or More Adverse Events

    Measured: Screening up to 30 days postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start11 Sep 2025
  3. Primary completion3 Mar 2026
  4. Study completion3 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07240116
Sponsor's protocol ID
CORT118335-859
Status last verified
Apr 2026
First submitted
7 Nov 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Miricorilant Treatment A, Miricorilant Treatment B and Miricorilant Treatment C in people with Healthy, run by Corcept Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of Maximum Observed Concentration (Tmax) of Miricorilant (time frame: Predose and at serial timepoints up to 72 hours postdose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07240116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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