This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects.
This food-interaction study will be conducted in healthy subjects. Each subject will have a screening visit (within the 21 days prior to the first study drug administration to confirm eligibility), 3 single-dose treatment periods separated by a 7- to 14- day washout between doses, and an outpatient end-of-study follow-up visit 14 +/- 2 days after the last dose of study medication. During each treatment period, subjects will receive a single 350-mg relacorilant dose. Based on randomization to 1 of 6 sequences, each subject will receive the relacorilant dose once after a 10.5 hour fast; once 30 minutes after the start of a high-fat meal; and once 30 minutes after the start of a moderate meal. During the first treatment period only, regardless of randomized sequence, subjects will report to the clinical research unit on the morning of Day -1 for baseline laboratory assessments and to collect samples for assay of messenger ribonucleic acid (mRNA) expression of glucocorticoid-modulated genes to explore the normal range over the day in healthy subjects. For the subsequent 2 treatment periods, subjects will report to the CRU on the evening of Day -1. Blood samples for assay of plasma concentration of relacorilant and its main metabolites will be collected pre-dose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, and 96 hours post-dose. Subjects and will remain in the clinic until after the 24-hour blood samples are collected and then be discharged and scheduled to return for the later samples. Additional samples will be collected for possible future pharmacogenomic analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast
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
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
Celerion
Tempe, Arizona, United States
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)
Time frame: predose to 96 hrs postdose
Area under plasma concentration-time curve extrapolated to infinity (AUCinf)
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 extrapolated to infinity (AUCinf)
Time frame: predose to 96 hrs postdose
Maximum plasma concentration (Cmax)
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 maximum plasma concentration (Cmax).
Time frame: predose to 96 hrs postdose
Adverse Events
Safety and tolerability measure by number of subjects who experience adverse events
Time frame: up to 9 weeks
Safety Labs
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in safety labs
Time frame: up to 9 weeks
ECGs
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in ECGs
Time frame: up to 9 weeks
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Vital Signs
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in vital signs
Time frame: up to 9 weeks
Physical Examinations
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in physical exams
Time frame: up to 9 weeks