Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

Sponsor
Corcept Therapeutics
Study ID
NCT04249323
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • CORT113176 Lipid Capsule Formulation — DRUG
    CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
  • Placebo matching CORT113176 Lipid Capsule Formulation — DRUG
    Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
  • Prednisone — DRUG
    Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration

Study Details

This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.

Key Dates

First listed
Jan 30, 2020
Start date
Jan 27, 2020
Status verified
Jan 2022
Primary completion
Oct 15, 2020
Completion
Oct 15, 2020

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1: SAD Cohorts A through H CORT113176
    Cohorts will receive a single dose of CORT113176 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. Cohort A will receive a 50-mg dose in a fasted state. Cohort B will receive a ≤3-fold increase in dose from Cohort A in a fasted state; the dose will be determined after evaluation of safety and PK data for Cohort A. Subsequent cohorts will receive a ≤3-fold increase in CORT113176 dose from the previous cohort in a fasted or fed state; the dose and prandial state will be determined after evaluation of safety and PK data from previous cohorts. Following interim review of PK data, an alternative lipidic formulation may be administered beginning with Cohort B.
  • Placebo Comparator: Part 1: SAD Cohorts A through H Placebo
    Cohorts will receive a single dose of placebo matching CORT113176 lipid capsule formulation by mouth on Day 1. The dose of placebo, prandial state, and choice of formulation will match that used for the corresponding SAD cohorts receiving CORT113176.
  • Experimental: Part 2: MAD Cohorts A through D CORT113176
    Cohorts will receive once- or twice-daily doses of CORT113176 lipid capsule formulation by mouth for 14 days. The anticipated exposure will not exceed the highest exposure considered safe and well-tolerated during Part 1. The dose schedule and prandial state will be determined after evaluation of safety and PK data from Part 1. The choice of formulation of CORT113176 to be used in Part 2 will depend on data review for Part 1.
  • Placebo Comparator: Part 2: MAD Cohorts A through D Placebo
    Cohorts will receive once- or twice-daily doses of placebo matching CORT113176 lipid capsule formulation by mouth for 14 days. The dose of placebo, prandial state, and choice of formulation will match that used for the corresponding MAD cohorts receiving CORT113176.
  • Experimental: Part 3: Single Dose Pharmacodynamic Effect
    In Period 1, participants will receive a single dose of prednisone 25 mg tablet by mouth on Day 1 in a fasted or fed state. After a 7-day washout, in Period 2, participants will receive a single dose of prednisone as in Period 1 plus a single dose of CORT113176 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. The dose of CORT113176 and the prandial state will be determined after evaluation of safety and PK data from Part 1. The choice of formulation of CORT113176 to be used in Part 3 will depend on data review for Part 1. Part 3 will proceed only if sufficiently high plasma CORT113176 exposure is achieved in Part 1.

Primary Outcome Measure

Number of Participants with One or More Adverse Events [ Time Frame: Part 1 SAD Cohorts: up to Day 9; Part 2 MAD Cohorts: up to Day 23; Part 3 Cohort: up to Day 19 ]

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