A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study
      conducted at a single study center to characterize the relative bioavailability of
      relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell
      capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy,
      fasted, adult subjects.

      Eligible subjects will participate in 3 treatment periods. During each treatment period,
      subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be
      randomized to each of 6 sequences.
    

Detailed description: 
      This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study.
      Eligible subjects will participate in 3 treatment periods. During each treatment period,
      subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be
      randomized to each of 6 sequences (i.e., ABC, BCA, CAB, BAC, ACB, and CBA):

      (A) relacorilant single 300 mg dose (3×100-mg softgel capsules) following a minimum 10 hour
      fast (Test 1) (B) relacorilant single 300 mg dose (3×100-mg hard-shell capsules) following a
      minimum 10-hour fast (Test 2) (C) relacorilant single 300 mg dose (6×50-mg hard-shell
      capsules) following a minimum 10 hour fast (Reference) Subjects will be admitted to the
      Clinical Research Unit (CRU) on the morning of Day -1 of each period following an 8-hour fast
      for baseline assessments and will remain confined until Day 3 of each period. After dosing in
      Period 1 and Period 2, subjects will undergo minimum 14 day washouts between doses of study
      drug. Subjects will then receive the next relacorilant dose in their randomized sequence in
      Period 2 and Period 3, respectively. Subjects will attend an outpatient Follow-up Visit 14±2
      days after the last dose of study drug in Period 3 (or Early Termination Visit).

      Blood samples will be collected before dosing and at intervals up to 120 hours after
      relacorilant dose in Periods 1, 2 and 3.

      Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead
      ECG recordings, vital signs, and physical examinations.
    

Intervention name(s): Relacorilant (3x100 mg softgel capsules); Relacorilant (3x100 mg hard-shell capsules); Relacorilant (6x50mg hard-shell capsules)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single relacorilant 300mg dose (3x100 mg softgel capsules) will be given once on Day 1 of one of three treatment periods.; A single relacorilant 300mg dose (3x100 mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods.; A single relacorilant 300mg dose (6x50mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods.
Other intervention name(s): CORT125134; CORT125134; CORT125134
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other