Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites

Exclusion Criteria

• •1. Be an employee or immediate family member of the Clinical Research Unit or Corcept.
• •2. Have been previously enrolled in any study of relacorilant.
• •3. Have multiple drug allergies, or be allergic to any of the components of Relacorilant and/or itraconazole.
• •4. Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition).
• •5. Have a history of malabsorption syndrome or previous gastrointestinal surgery, with the exception of appendectomy and cholecystectomy, which could affect drug absorption or metabolism.
• •6. Current alcohol or substance abuse.
• •7. In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL.
• •8. In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine.
• •9. Have a positive test for alcohol or drugs of abuse at screening or first admission.
• •10. Have clinically relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at screening and/or before first study drug administration, including but not limited to\*\*:
• •1. QT interval corrected for heart rate (QTc) using Fridericia's equation (QTcF) \>450 ms (from mean of 3 supine ECGs, performed at least 2 minutes apart)
• •2. Stage 2 or higher hypertension (supine/semi-recumbent systolic blood pressure \[SBP\] \>160 mmHg, diastolic blood pressure \[DBP\] \>100 mmHg; based on mean of duplicate values recorded at least 2 minutes apart)
• •3. Stage 1 hypertension (supine/semi-recumbent SBP 140-160 mmHg, DBP 90-100 mmHg; based on mean of duplicate values recorded at least 2 minutes apart) associated with indication for treatment ie, evidence of end-organ damage, diabetes, or a 10-year cardiovascular risk, estimated using a standard calculator, (eg, QRISK2-2016) greater than 20%
• •4. Glomerular filtration rate, estimated using the chronic kidney disease epidemiology (collaboration) (CKD-EPI) method (eGFR; Levey 2009) \<60 mL/minute/1.73 m2
• •5. Hypokalemia (potassium below lower limit of normal)
• •6. Alanine aminotransferase (ALT), aspartate amino transferase (AST), and/or gamma- glutamyltransferase (GGT) \>1.5 times the upper limit of normal (ULN)
• •7. Seropositive for hepatitis B, hepatitis C, or human immunodeficiency (HIV) viruses \*\*For purposes of qualifying any given subject for study participation, out-of-range values may be repeated once.
• •11. Have any medical or social reasons for not participating in the study raised by their primary care physician.
• •12. Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator.
• •13. Taken any prohibited prior medication within protocol designated timeframes, such as or including any glucocorticoid, strong inducers, inhibitors or substrates of CYP enzymes involved in drug-drug-interactions, hormonal contraception or hormone replacement therapy.