Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants

Inclusion criteria

• Be capable of and willing to comply with study restrictions and procedures
• Female participants must be non-nursing, have a negative pregnancy test result at screening and Day -1, and be surgically sterile for at least 90 days prior to screening or postmenopausal
• Male participants with female partners of child bearing potential must agree to use 2 acceptable forms of birth control for the duration of the study and for 90 days following the last administration of the drug; all male participants must refrain from donating sperm for this same period
• Be considered healthy by the Investigator, based on participant's reported medical history, full physical examination, clinical laboratory tests, 12-lead electrocardiograms (ECG) and vital signs
• Have normal renal function as determined by Investigator
• Have a body mass index (BMI) of 18.0 to 30.0 kg/m^2 inclusive and body weight >50.0 kg at screening
• Have no relevant dietary restrictions
• Be willing to comply with COVID-19 policy

Exclusion criteria

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, psychiatric, neurologic, immunologic or lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
• Known or suspected malignancy
• History of pancreatitis or gall stones
• History of unexplained syncope, symptomatic hypotension, or hypoglycemia
• Personal or family history of long QTc syndrome; QTcF >450 ms
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance
• Gastrointestinal, liver, kidney disease, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion within 3 months prior to the screening and during the screening period
• Hypersensitivity to dazucorilant or itraconazole or any components of either formulation
• Poor venous access
• Positive blood screen for infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Donated or lost ≥500 mL of blood in the previous 60 days
• Plasma donation within 30 days prior to the 1st dose of study medication
• Taken an investigational drug or participated in a clinical trial within 90 days (or 5 half-lives), whichever is longer, prior to the 1st dose of study medication
• Used prescription or over-the-counter (OTC) medication (other than ≤1 g/day acetaminophen), antacids, vitamins or herbal remedies or supplements, within 2 weeks or 5 half-lives before first study drug administration, whichever is longer
• Used food or drugs that are inducers of CYP3A4/5 and/or P-glycoprotein inducers within 30 days prior to the first dose of study medication
• Consumption of grapefruit, pomelo, or Seville oranges or their juices or jams, from 30 days prior to Day -1
• Hospital admission or major surgery within 6 months prior to screening or a preplanned hospital admission during study participation
• A history of prescription drug abuse or illicit drug use within 12 months prior to screening
• Use of cannabis or cannabidiol (CBD) containing products within 30 days prior to study drug administration on Day 1
• A history of alcohol abuse according to medical history within 2 years prior to screening
• Use of tobacco- or nicotine-containing products or participants unwilling/unable to stop nicotine intake from 6 months prior to screening until the end of the study
• A positive screen for alcohol, drugs of abuse, or cotinine at screening or Day -1
• An unwillingness or inability to comply with food and beverage restrictions during study participation
• Investigational site staff members directly involved in the conduct of the study and their family members; site staff members otherwise supervised by the Investigator or Corcept Therapeutics Incorporated employees directly involved in the conduct of the study
• Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study
• Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded