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

Primary Purpose

Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Miricorilant
Fluvoxamine
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antipsychotic Induced Weight Gain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Site 01

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Miricorilant - Fluvoxamine/Miricorilant

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration of miricorilant (Cmax)
Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last)
Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf)

Secondary Outcome Measures

Number of participants with one or more treatment-emergent adverse events (TEAEs)
Number of participants with one or more serious adverse events (SAEs)
Number of participants with a clinically-significant vital sign abnormality
Number of participants with a clinically-significant laboratory test abnormality

Full Information

First Posted
January 25, 2023
Last Updated
March 20, 2023
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05712265
Brief Title
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Miricorilant - Fluvoxamine/Miricorilant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Miricorilant
Other Intervention Name(s)
CORT118335
Intervention Description
Miricorilant 6 x 100 mg coated tablets
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine
Intervention Description
Fluvoxamine 50 mg tablet
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
Number of participants with one or more treatment-emergent adverse events (TEAEs)
Time Frame
Up to 30 days after study drug administration
Title
Number of participants with one or more serious adverse events (SAEs)
Time Frame
Up to 30 days after study drug administration
Title
Number of participants with a clinically-significant vital sign abnormality
Time Frame
Up to Day 13
Title
Number of participants with a clinically-significant laboratory test abnormality
Time Frame
Up to Day 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Custodio, PhD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 01
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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