Healthy Clinical Trial
Official title:
A Phase I Adaptive Dose, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT118335 in Healthy Subjects
This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects.
This is a 5-part, single-center study of single and multiple ascending doses of CORT118335 in
healthy subjects.
Parts I and 4 of the study are double-blind, randomized, placebo-controlled assessments of
single-ascending doses (SAD) of CORT118335. Subjects will be enrolled sequentially into 1 of
up 8 cohorts (Part 1, Cohorts A to D [Cohorts E to G have been cancelled]; Part 4, Cohorts A
to D), each containing 8 subjects. Within each cohort, 6 subjects will be randomly assigned
to receive a single dose of CORT118335 and 2 subjects will be randomly assigned to receive a
single dose of matching placebo.
Part 2 Cohort A, food-effect, will be an open-label 2-way crossover study in one cohort of 12
subjects, randomized in a 1:1 ratio to receive a single dose of CORT118335 once after an
overnight fast and once after a high-fat breakfast or the alternate sequence, over 2 study
periods separated by a washout of at least 7 days/5 half-lives.
Part 2 Cohort B, PD cohort, will be a double-blind, randomized, placebo-controlled, 3-way
cross-over study and will serve as proof of pharmacological effect (GR modulation) for
CORT118335. Subjects will be randomized in a 1:1:1 ratio to receive placebo, and two dose
levels of CORT118335 in one of three treatment sequences across 3 study periods separated by
washouts of at least 7 days/5 half-lives. On each occasion, the ability of CORT118335 to
ameliorate the pharmacological effects of a single dose of prednisone will be measured.
Parts 3 and 5 are double-blind, randomized, placebo-controlled assessments of multiple oral
ascending doses of CORT118335. Subjects will be enrolled sequentially into 1 of up to 4
cohorts (Part 1 Cohort A [Cohorts B to D have been cancelled; Part 5 Cohorts A to C), each
containing 12 subjects. Within each cohort, 9 subjects will be randomly assigned to receive
CORT118335 and 3 subjects to receive matching placebo daily for 14 days.
Different formulations of CORT118335 will be used in Parts 1, 2 and 3, and in Parts 4 and 5.
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