Healthy Clinical Trial
Official title:
A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Subjects to Determine the Effect of an Inhibitor of Cytochrome P450 3A on Exposure to Relacorilant and Its Main Metabolites
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will
participate in 3 treatment periods, in which they will receive the following treatments in
turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period
2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single
350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and
continued once daily 200-mg doses of itraconazole for three additional days.
If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which
they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses
of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in
combination with once daily 200-mg doses of itraconazole for 10 days.
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will
participate in 3 treatment periods, in which they will receive the following treatments in
turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period
2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single
350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and
continued once daily 200-mg doses of itraconazole for three additional days.
Part 2 of the study may be conducted if the results of Part 1 indicate that itraconazole has
a clinically meaningful effect on exposure to relacorilant and metabolites. If Part 2 is
conducted, eligible subjects will participate in 2 treatment periods, in which they will
receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of
relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in
combination with once daily 200-mg doses of itraconazole for 10 days.
Blood samples will be collected before dosing and at intervals up to 96 hours after
relacorilant dose in Part 1, and up to 24 hours after the last dose of relacorilant in each
study period in Part 2. In Part 1 only, additional samples will be collected during the
itraconazole dosing to confirm exposure.
Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead
ECG recordings, vital signs, and and physical examinations.
Subjects will be admitted to the Clinical Research Unit (CRU) on the morning of Day −1
following an 8-hour fast for baseline assessments and will remain confined until completion
of procedures. Each subject will have a follow-up (FU) visit 14 ± 2 days (Part 1) or 7 ± 2
days (Part 2) after the last dose of relacorilant.
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