Healthy Clinical Trial
Official title:
A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAD and MAD of CORT125281 in Healthy Subjects
This initial Phase I study will evaluate the dose-related safety and tolerability pharmacokinetics (PK) of CORT125281, and CORT125324 (active metabolite), and pharmacodynamics (PD) after single and multiple ascending oral doses of CORT125281 in healthy subjects.
Separate single-and multiple-ascending dose (SAD and MAD) parts will be conducted. Throughout
each part of the study, safety, pharmacological (PD) and PK effects will be assessed. Safety
and tolerability will be assessed using adverse event (AE) monitoring, measurement of vital
signs, recording 12-lead electrocardiogram (ECG), physical examination and clinical
laboratory safety tests. Blood samples will be collected at intervals for assay of plasma
concentration of CORT125281 and CORT125324.
The SAD part of the study is double-blind, randomized and placebo-controlled with respect to
CORT125281. Two cohorts, each of 9 subjects, will receive three sequential single doses of
the investigational medicinal product (IMP), either CORT125281 at the assigned dose level or
placebo, in a partial within-subject crossover manner. The starting dose is CORT125281, 40
mg; the rules for determining later doses are detailed within the protocol. The PD effects of
CORT125281 will be examined by testing its ability to ameliorate the pharmacological effects
of a concomitantly administered dose of prednisone.
The MAD part of the study will be double-blind, randomized, placebo-controlled and
parallel-group with respect to CORT125281. Up to four cohorts of 8 subjects, randomized so
that 6 receive CORT125281 and 2 receive placebo, will participate in the study, so that up to
four dose levels of CORT125281 are studied in total. An exploratory assessment will be made
of the effect of repeated doses of CORT125281 on exposure to pioglitazone, probe substrate
for CYP2C8. Each subject will be admitted on Day−1 for baseline assessments. On Day1,
subjects will receive a single oral dose of pioglitazone, 15mg. From Day3 to Day16 (14 days),
subjects will be dosed daily with IMP (CORT125281 at the selected dose or placebo). On Day13,
subjects will receive a second dose of pioglitazone, 15 mg.
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