A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants

NCT03540836 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT125134-127
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study conducted at a single study center to characterize the relative bioavailability of relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy, fasted, adult subjects. Eligible subjects will participate in 3 treatment periods. During each treatment period, subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be randomized to each of 6 sequences.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  Ratio of population geometric means (GMR) of AUC0-tz for Test 1 (relacorilant 3×100-mg softgel capsules) and Reference (relacorilant 6×50-mg hard-shell capsules) and for Test 2 (relacorilant 3×100-mg hard-shell capsules) and Reference (relacorilant 6×50-mg hard-shell capsules)

  pre-dose to 120 hours post-dose in Periods 1 -3.

Secondary Outcomes (4)

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

  pre-dose to 120 hours post-dose in Periods 1-3

• Maximum plasma concentration (Cmax)

  pre-dose to 120 hours post-dose in Periods 1-3

• Time to Maximum plasma concentration (Tmax)

  pre-dose to 120 hours post-dose in Periods 1-3

• Adverse Events

  up to 30 days after the last dose of study drug

Study Arms (3)

Relacorilant 3x100mg softgel capsules

EXPERIMENTAL

Relacorilant (3x100 mg softgel capsules)

Drug: Relacorilant (3x100 mg softgel capsules)

Relacorilant 3x100mg hard-shell capsules

EXPERIMENTAL

Relacorilant (3x100 mg hard-shell capsules)

Drug: Relacorilant (3x100 mg hard-shell capsules)

Relacorilant 6x50mg hard-shell capsules

EXPERIMENTAL

Relacorilant (6x50mg hard-shell capsules)

Drug: Relacorilant (6x50mg hard-shell capsules)

Interventions

Relacorilant (3x100 mg softgel capsules) DRUG

A single relacorilant 300mg dose (3x100 mg softgel capsules) will be given once on Day 1 of one of three treatment periods.

Also known as: CORT125134

Relacorilant 3x100mg softgel capsules

Relacorilant (3x100 mg hard-shell capsules) DRUG

A single relacorilant 300mg dose (3x100 mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods.

Also known as: CORT125134

Relacorilant 3x100mg hard-shell capsules

Relacorilant (6x50mg hard-shell capsules) DRUG

A single relacorilant 300mg dose (6x50mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods.

Also known as: CORT125134

Relacorilant 6x50mg hard-shell capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Give written informed consent.
• 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.
• Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight more than 50 kg (110 pounds).
• 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.
• Be willing to comply with study restrictions
• Have suitable veins for multiple venipuncture/cannulation.
• Female subjects must be either of nonchildbearing potential (i.e., 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.

You may not qualify if:

• Be an employee or immediate family member of the Clinical Research Unit or Corcept.
• Have been previously enrolled in any study of relacorilant.
• Have multiple drug allergies or be allergic to any of the components of relacorilant.
• Have a condition that could be aggravated by glucocorticoid blockade (e.g., asthma, any chronic inflammatory condition).
• Have a history of malabsorption syndrome or previous gastrointestinal surgery, with the exception of appendectomy and cholecystectomy, which could affect drug absorption or metabolism.
• Current, or previous within a 1-year period, alcohol or substance abuse.
• In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL.
• In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine.
• Have a positive test for alcohol or drugs of abuse at screening or first admission.
• 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\*\*:
• 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)
• 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)
• 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 i.e., evidence of end-organ damage, diabetes, or a 10-year cardiovascular risk, estimated using a standard calculator, (e.g., QRISK2-2016) greater than 20%
• Estimated glomerular filtration rate \<60 mL/minute/1.73 m2, estimated using the Chronic Kidney Disease Epidemiology Collaboration method (Levey 2009)
• Hypokalemia (potassium below lower limit of normal)

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

relacorilant

Study Officials

• Ada Lee, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: May 24, 2018
• Primary Completion: July 16, 2018
• Study Completion: July 25, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-08

Locations

US (1)