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 atscreening and Day -1, and be surgically sterile for at least 90 days prior toscreening 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 daysfollowing the last administration of the drug; all male participants must refrainfrom donating sperm for this same period

• Be considered healthy by the Investigator, based on participant's reported medicalhistory, full physical examination, clinical laboratory tests, 12-leadelectrocardiograms (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 >50.0kg 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 bythe 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 allergiesor intolerance

• Gastrointestinal, liver, kidney disease, or other diseases known to interfere withdrug absorption, distribution, metabolism, or excretion within 3 months prior to thescreening and during the screening period

• Hypersensitivity to dazucorilant or itraconazole or any components of eitherformulation

• 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/dayacetaminophen), antacids, vitamins or herbal remedies or supplements, within 2 weeksor 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 inducerswithin 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 apreplanned hospital admission during study participation

• A history of prescription drug abuse or illicit drug use within 12 months prior toscreening

• Use of cannabis or cannabidiol (CBD) containing products within 30 days prior tostudy drug administration on Day 1

• A history of alcohol abuse according to medical history within 2 years prior toscreening

• Use of tobacco- or nicotine-containing products or participants unwilling/unable tostop 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 duringstudy participation

• Investigational site staff members directly involved in the conduct of the study andtheir family members; site staff members otherwise supervised by the Investigator orCorcept Therapeutics Incorporated employees directly involved in the conduct of thestudy

• Any condition or finding that in the Investigator's opinion would put theparticipant or study conduct at risk if the participant were to participate in thestudy

• Unable to complete this study for other reasons or the Investigator believes that heor she should be excluded