The primary objectives of this study are to evaluate the clinical responder rate, defined as
the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the
Maintenance Phase without dose increase, and to evaluate the range of effective doses in
subjects with various levels of hypercortisolism.
A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
Completed
Cortendo AB
Phase 3
2017-09-26
This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration
study in subjects with endogenous CS previously treated with single-arm, open-label
levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of
levoketoconazole.
Levoketoconazole Food Effect Study in Healthy Subjects
Completed
Cortendo AB
Phase 1
2018-11-30
This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover
study in healthy male and female subjects to evaluate the effect of food on the PK of
levoketoconazole.
Drug Interaction Study of Levoketoconazole and Metformin
Completed
Cortendo AB
Phase 1
2019-03-28
This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the
effect of levoketoconazole on the single-dose PK of metformin in health subjects.
Bioavailability of Levoketoconazole and Ketoconazole Tablets
Completed
Cortendo AB
Phase 1
2019-12-16
This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover
study in healthy male and female subjects to evaluate the relative oral bioavailability of
levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug
product).
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