Relacorilant Food Effect Study in Healthy Subjects

NCT03442621 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT125134-123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects.

Conditions

Healthy; Food-drug Interaction

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) for Test 1 (standard high fat breakfast) and Reference (fasted) and for Test 2 (standard moderate breakfast) and Reference for relacorilant areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)

  predose to 96 hrs postdose

Secondary Outcomes (7)

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

  predose to 96 hrs postdose

• Maximum plasma concentration (Cmax)

  predose to 96 hrs postdose

• Adverse Events

  up to 9 weeks

• Safety Labs

  up to 9 weeks

• ECGs

  up to 9 weeks

Study Arms (3)

Relacorilant Fasted

EXPERIMENTAL

Relacorilant Fasted

Drug: Relacorilant Fasted

Relacorilant with a high fat breakfast

EXPERIMENTAL

Relacorilant with a high fat breakfast

Drug: Relacorilant with a high fat breakfast

Relacorilant with a moderate breakfast

EXPERIMENTAL

Relacorilant with a moderate breakfast

Drug: Relacorilant with a moderate breakfast

Interventions

Relacorilant Fasted DRUG

Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast

Also known as: Relacorilant, CORT125134

Relacorilant Fasted

Relacorilant with a high fat breakfast DRUG

Relacorilant presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a high fat breakfast

Also known as: Relacorilant, CORT125134

Relacorilant with a high fat breakfast

Relacorilant with a moderate breakfast DRUG

Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a moderate breakfast

Also known as: Relacorilant, CORT125134

Relacorilant with a moderate breakfast

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 (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.

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 (eg, asthma, any chronic inflammatory condition).
• Have a history of gastric bypass surgery.
• 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 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 a positive test for exogenous glucocorticoids at screening.
• 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 ie, evidence of end-organ damage, diabetes, or a 10-year cardiovascular risk, estimated using a standard calculator, (eg, QRISK2-2016) greater than 20%

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

relacorilant

Study Officials

• Kirsteen Donaldson, FFPM,DM,FRCP

  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: January 23, 2018
• First Posted: February 22, 2018
• Study Start: January 16, 2018
• Primary Completion: February 28, 2018
• Study Completion: March 9, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-02

Locations

US (1)