Overview
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
Status:
Recruiting
Recruiting
Trial end date:
2023-02-24
2023-02-24
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Corcept TherapeuticsTreatments:
Fluvoxamine
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.