Healthy Clinical Trial
Official title:
A Phase 1, Open-label, Single-dose, Randomized, Crossover Study in Healthy Subjects of the Effects of Co-administration With Food on Exposure, and to Determine the Within-subject Variability in Exposure, to Relacorilant and Its Metabolites
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.
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