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CORT113176 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Study Participants | EXPERIMENTAL | On Day 1, participants will receive a single oral dose of \[14C\]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state. |
| Cohort 1: CORT113176 150 mg | EXPERIMENTAL | Participants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. |
| Cohort 1: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Cohort 2: CORT113176 300 mg | EXPERIMENTAL | Participants will receive CORT113176 300 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Progression from Cohort 1 to 2 will be done based on safety and tolerability outcome from Cohort 1 and only after Cohort 1 has received study drug for ≥7 days. |
| Cohort 2: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Cohort 3: CORT113176 ≥300 mg | EXPERIMENTAL | Participants will receive CORT113176 ≥300 mg not to exceed 450 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Cohort 3 is optional, and progression from Cohort 2 to 3 be done based on safety and tolerability outcome from Cohort 2 and only after Cohort 2 has received study drug for ≥7 days. |
| Cohort 3: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Name | Type | Description |
|---|---|---|
| [14C]-CORT113176 | DRUG | \[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C. |
| CORT113176 | DRUG | CORT113176 lipid capsule formulation for oral administration |
| Placebo matching CORT113176 | DRUG | Placebo matching CORT113176 lipid capsule formulation for oral administration |
Inclusion Criteria: * Body mass index 18.0 to 30.0 kg/m\^2, inclusive * Willing and able to participate in the whole study * Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day) * Provide written informed consent * Adhere to the contraception requirements. Excl...
CORT113176 is an investigational small molecule being developed by Corcept Therapeutics Incorporated (ticker: CORT). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to assess its safety, tolerability, and pharmacokinetics, as well as its absorption, distribution, metabolism, and excretion.
CORT113176 is being studied in healthy adults and healthy male participants. It is an investigational drug in Phase 1 clinical trials. The studies are designed to evaluate the safety, tolerability, and pharmacokinetics of the drug, as well as its absorption, distribution, metabolism, and excretion in the body.
CORT113176 is being developed by Corcept Therapeutics Incorporated, a company listed on the stock exchange under the ticker CORT. The drug is currently in Phase 1 clinical development, with studies conducted in healthy volunteers in the United Kingdom and the Netherlands.
CORT113176 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, one evaluating safety, tolerability, and pharmacokinetics in healthy participants, and another studying the absorption, distribution, metabolism, and excretion of the drug in healthy male participants.
CORT113176 has been studied in two completed Phase 1 clinical trials. NCT04990310 was a single-dose study of [14C]-CORT113176 in healthy male participants in the United Kingdom, with 6 participants. NCT04994743 was a safety, tolerability, and pharmacokinetic study in healthy participants in the Netherlands, with 16 participants.
CORT113176 is an investigational small molecule developed by Corcept Therapeutics. It is not known to be the same as any other approved drug. It is currently in Phase 1 clinical trials, and no alternative names have been reported for this compound.