Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Relacorilant 350mg; Itraconazole; Relacorilant 300mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Relacorilant 350mg; Itraconazole 200 mg; Relacorilant 300mg
Other intervention name(s): CORT125134; Sporanox; CORT125134
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other