Antipsychotic Induced Weight GainPhase 1NCT05712265
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
A Phase 1 study testing Miricorilant and Fluvoxamine in people with Antipsychotic Induced Weight Gain and Non-alcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- Miricorilant and Fluvoxamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 23 Feb 2023
- 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 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Miricorilant, Fluvoxamine
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiricorilantDrug
Also called CORT118335
Miricorilant 6 x 100 mg coated tablets
FluvoxamineDrug
Fluvoxamine 50 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Miricorilant - Fluvoxamine/Miricorilant | Experimental | 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. Receives: Drug: Miricorilant; Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration of miricorilant (Cmax)
Measured: 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)
Measured: 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)
Measured: 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 (4)
Number of participants with one or more treatment-emergent adverse events (TEAEs)
Measured: Up to 30 days after study drug administration
Number of participants with one or more serious adverse events (SAEs)
Measured: Up to 30 days after study drug administration
Number of participants with a clinically-significant vital sign abnormality
Measured: Up to Day 13
Number of participants with a clinically-significant laboratory test abnormality
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start24 Jan 2023
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antipsychotic Induced Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Custodio, PhD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712265
- Sponsor's protocol ID
- CORT118335-856
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05712265
- Acronym / sponsor ID
- CORT118335-856
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miricorilant - Fluvoxamine/Miricorilant | Experimental | Drug: Miricorilant, Drug: FluvoxamineParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiricorilantAlso: CORT118335Miricorilant 6 x 100 mg coated tablets | Drug | Miricorilant - Fluvoxamine/Miricorilant |
| FluvoxamineFluvoxamine 50 mg tablet | Drug | Miricorilant - Fluvoxamine/Miricorilant |
Primary outcome
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
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
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
4 secondary outcomes
Number of participants with one or more treatment-emergent adverse events (TEAEs)
Time frame: 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
Number of participants with a clinically-significant vital sign abnormality
Time frame: Up to Day 13
Number of participants with a clinically-significant laboratory test abnormality
Time frame: Up to Day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Custodio, PhD study director
Corcept Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Miricorilant and Fluvoxamine in people with Antipsychotic Induced Weight Gain and Non-alcoholic Steatohepatitis (NASH), 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 25 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 22 Mar 2023. 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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.