Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Corcept Therapeutics Incorporated (NASDAQ: CORT). It is currently in Phase 1 clinical development, studied in healthy adults. The drug is a lipid formulation of CORT113176, and its development is focused on evaluating its safety and tolerability in early-stage trials.
CORT113176 Lipid Formulation is being studied for use in healthy adults as part of early clinical development. The current clinical trial is a single and multiple ascending dose study designed to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy participants. It is not yet approved for any medical condition.
CORT113176 Lipid Formulation is developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol CORT. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
CORT113176 Lipid Formulation is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 trial, NCT04249323, has been completed, evaluating single and multiple ascending doses in healthy participants.
CORT113176 Lipid Formulation has one completed Phase 1 clinical trial, NCT04249323, titled 'Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants.' The trial enrolled 110 healthy adults in the United Kingdom, was randomized, double-blind, and placebo-controlled. It is not currently active in any ongoing trials.