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CompletedNCT03512548Updated Mar 24, 2020

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

A Phase 1 interventional study of Relacorilant 350mg and Itraconazole in Healthy, sponsored by Corcept Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Corcept Therapeutics · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2019, 7 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.

If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.

Read the detailed description

This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.

Part 2 of the study may be conducted if the results of Part 1 indicate that itraconazole has a clinically meaningful effect on exposure to relacorilant and metabolites. If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.

Blood samples will be collected before dosing and at intervals up to 96 hours after relacorilant dose in Part 1, and up to 24 hours after the last dose of relacorilant in each study period in Part 2. In Part 1 only, additional samples will be collected during the itraconazole dosing to confirm exposure.

Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead ECG recordings, vital signs, and and physical examinations.

Subjects will be admitted to the Clinical Research Unit (CRU) on the morning of Day -1 following an 8-hour fast for baseline assessments and will remain confined until completion of procedures. Each subject will have a follow-up (FU) visit 14 ± 2 days (Part 1) or 7 ± 2 days (Part 2) after the last dose of relacorilant.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Part 1 Period 1

    Part 1 Period 1: Relacorilant 350mg will be given once on Day 1

    Drug: Relacorilant 350mg

  • Experimental
    Part 1 Period 2

    Part 1 Period 2: Itraconazole 200mg will be given for three days

    Drug: Itraconazole

  • Experimental
    Part 1 Period 3

    Part 1 Period 3: Relacorilant 350mg will be given once with concomitant itraconazole and itraconazole will continue for three additional days

    Drug: Relacorilant 350mg · Drug: Itraconazole

  • Experimental
    Part 2 Period A

    Part 2 Period A: Relacorilant 300mg will be given once daily for 10 days

    Drug: Relacorilant 300mg

  • Experimental
    Part 2 Period B

    Part 2 Period B: Relacorilant 300mg will be given once daily in combination with itraconazole 200mg once daily for 10 days

    Drug: Itraconazole · Drug: Relacorilant 300mg

Interventions

  • DrugRelacorilant 350mg

    Relacorilant 350mg

    Also known as: CORT125134

  • DrugItraconazole

    Itraconazole 200 mg

    Also known as: Sporanox

  • DrugRelacorilant 300mg

    Relacorilant 300mg

    Also known as: CORT125134

06

What researchers measure

Primary outcomes

  1. Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)

    Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)

    Time frame: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2

Secondary outcomes

  1. Area under plasma concentration-time curve extrapolated to infinity (AUCinf)

    Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) areas under plasma concentration-time curve extrapolated to infinity (AUCinf)

    Time frame: predose to 96 hrs postdose in Part 1; AUCinf not calculated in Part 2 due to steady state evaluation

  2. Maximum plasma concentration (Cmax)

    Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) maximum plasma concentration (Cmax).

    Time frame: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2

  3. Number and Severity of Treatment Emergent Adverse Events

    Treatment Emergent Adverse Events will be summarized overall and by treatment based on their frequency and severity of treatment emergent adverse events

    Time frame: up to 7 weeks in Part 1 and up to 7 weeks in Part 2

07

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03512548
Lead sponsor
Corcept Therapeutics
Responsible party
Sponsor
First posted
Apr 30, 2018
Start date
Apr 10, 2018
Primary completion
Jul 29, 2019
Completion
Aug 23, 2019
Last update
Mar 24, 2020

Study contacts

Joseph Custodio, PhD
study director · Corcept Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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