Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT03512548
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 30, 2018
Start date
Apr 10, 2018
Status verified
Mar 2020
Primary completion
Jul 29, 2019
Completion
Aug 23, 2019

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Part 1 Period 1
    Part 1 Period 1: Relacorilant 350mg will be given once on Day 1
  • Experimental: Part 1 Period 2
    Part 1 Period 2: Itraconazole 200mg will be given for three days
  • Experimental: Part 1 Period 3
    Part 1 Period 3: Relacorilant 350mg will be given once with concomitant itraconazole and itraconazole will continue for three additional days
  • Experimental: Part 2 Period A
    Part 2 Period A: Relacorilant 300mg will be given once daily for 10 days
  • Experimental: Part 2 Period B
    Part 2 Period B: Relacorilant 300mg will be given once daily in combination with itraconazole 200mg once daily for 10 days

Primary Outcome Measure

Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz) [ Time Frame: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

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Celerion· Tempe, AZ

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