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Also known as CORT113176 Lipid Capsule Formulation
CORT113176 Lipid Formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD Cohorts A through H CORT113176 | EXPERIMENTAL | 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. |
| Part 1: SAD Cohorts A through H Placebo | PLACEBO_COMPARATOR | 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. |
| Part 2: MAD Cohorts A through D CORT113176 | EXPERIMENTAL | 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. |
| Part 2: MAD Cohorts A through D Placebo | PLACEBO_COMPARATOR | 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. |
| Part 3: Single Dose Pharmacodynamic Effect | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * Body mass index (BMI) 18.0 to 30.0 kg/m\^2, inclusive * Body weight ≤102 kg * Willing to consume a high-fat breakfast, including pork * Agrees to adhere to the contraception requirements of the protocol * Additional criteria apply. Exclusion Criteria: * Received any investig...
CORT113176 Lipid Formulation is an investigational small molecule developed by Corcept Therapeutics Incorporated. It is a lipid capsule formulation of CORT113176 that has been studied in a Phase 1 clinical trial in healthy adult participants. The specific therapeutic indications for this drug candidate have not been publicly disclosed.
CORT113176 Lipid Formulation is being developed by Corcept Therapeutics Incorporated, which trades on the Nasdaq under the ticker CORT. Corcept is the sponsor of the clinical program evaluating this lipid capsule formulation of CORT113176.
CORT113176 Lipid Formulation is in Phase 1 clinical development. Its single Phase 1 trial, NCT04249323, has been completed. The drug is investigational and has not been approved by the FDA for any indication.
CORT113176 Lipid Formulation has been evaluated in one Phase 1 trial, NCT04249323, titled a Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants. The trial was completed, enrolled 110 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United Kingdom.
Yes, CORT113176 Lipid Formulation and CORT113176 Lipid Capsule Formulation refer to the same investigational drug candidate from Corcept Therapeutics. The two names describe the same lipid capsule formulation of CORT113176 studied in the completed Phase 1 trial NCT04249323.