Eligibility Details:
Inclusion Criteria:
1. Able to understand the purpose and risks of the study; willing and able to adhere to
scheduled visits, treatment plans, laboratory tests, and other study evaluations and
procedures.
2. Give written informed consent.
3. Be males or nonpregnant, nonlactating females judged to be in good health, based on
the results of medical history, physical examination, vital signs, 12-lead ECG, and
clinical laboratory findings.
4. Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight
more than 50 kg (110 pounds).
5. Be a nonsmoker. Use of nicotine or nicotine-containing products must be discontinued
at least 90 days prior to the first dose of study drug.
6. Be willing to comply with study restrictions
7. Have suitable veins for multiple venipuncture/cannulation.
8. Female subjects must be either of nonchildbearing potential (ie, postmenopausal or
permanently sterilized) or use highly effective contraception with low
user-dependency.
- The only acceptable method of highly effective contraception with low
user-dependency is an intrauterine device (IUD). Use of hormonal contraception
(by any route, including intrauterine hormone releasing systems) or hormone
replacement therapy is NOT acceptable.
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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
