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
Overview
- Phase
- Phase 1
- Intervention
- Miricorilant
- Conditions
- Antipsychotic Induced Weight Gain
- Sponsor
- Corcept Therapeutics
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: Miricorilant
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.
Intervention: Fluvoxamine
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Number of participants with one or more treatment-emergent adverse events (TEAEs)(Up to 30 days after study drug administration)
- Number of participants with a clinically-significant vital sign abnormality(Up to Day 13)
- Number of participants with one or more serious adverse events (SAEs)(Up to 30 days after study drug administration)
- Number of participants with a clinically-significant laboratory test abnormality(Up to Day 13)