A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT03540836
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, 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.

Key Dates

First listed
May 30, 2018
Start date
May 24, 2018
Status verified
Aug 2018
Primary completion
Jul 16, 2018
Completion
Jul 25, 2018

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Relacorilant 3x100mg softgel capsules
    Relacorilant (3x100 mg softgel capsules)
  • Experimental: Relacorilant 3x100mg hard-shell capsules
    Relacorilant (3x100 mg hard-shell capsules)
  • Experimental: Relacorilant 6x50mg hard-shell capsules
    Relacorilant (6x50mg hard-shell capsules)

Primary Outcome Measure

Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz) [ Time Frame: pre-dose to 120 hours post-dose in Periods 1 -3. ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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