Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-CORT113176, Dazucorilant
CORT113176 · 4 trials · 4 indications
This outcome measure is assessed in study Part 1.
This outcome measure is assessed in study Part 1.
This outcome measure is assessed in study Part 2.
This outcome measure is assessed in study Part 2.
| Arm | Type | Description |
|---|---|---|
| Part 1: CORT113176 (Dazucorilant) 300 mg | EXPERIMENTAL | 300 mg of dazucorilant will be administered once daily. |
| Part 1: CORT113176 (Dazucorilant) 150 mg | EXPERIMENTAL | 150 mg of dazucorilant will be administered once daily. |
| Part 1: Placebo (matched to study drug) | PLACEBO_COMPARATOR | Placebo will be administered once daily. |
| Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration | EXPERIMENTAL | 75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily. |
| Moderate Hepatic Impairment | EXPERIMENTAL | On Day 1, each participant with moderate hepatic impairment will receive a single oral dose of dazucorilant 300 mg. |
| Matched Healthy Participants | EXPERIMENTAL | Healthy participants will be matched to those with moderate hepatic impairment as to gender, age (± 10 years of the mean), and weight (± 20% of the mean). On Day 1, each healthy participant will receive a single oral dose of dazucorilant 300 mg. |
| Mild Hepatic Impairment | EXPERIMENTAL | On Day 1, each participant with mild hepatic impairment will receive a single oral dose of dazucorilant 300 mg. This arm may be enrolled after review of interim PK evaluation of the effects of moderate hepatic impairment. |
| 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 |
|---|---|---|
| Dazucorilant 300 mg | DRUG | 300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule. |
| Dazucorilant 150 mg | DRUG | Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent. |
| Placebo | OTHER | Placebo will be administered once daily in capsules of placebo equivalent. |
| Dazucorilant | DRUG | Dazucorilant will be administered once daily in 75-mg capsules. |
| [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: * Male and female patients ≥18 years of age with sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progre...
CORT113176 is an investigational small molecule developed by Corcept Therapeutics Incorporated. It has been studied in Phase 1 clinical trials involving healthy adult male participants. The specific therapeutic indication for CORT113176 has not been disclosed.
CORT113176 is being developed by Corcept Therapeutics Incorporated, which trades on the Nasdaq under the ticker CORT. The company has sponsored two completed Phase 1 clinical trials of the drug in healthy male volunteers.
CORT113176 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one safety, tolerability, and pharmacokinetic study in the Netherlands, and one absorption, distribution, metabolism, and excretion study in the United Kingdom. No later-phase trials have been registered.
CORT113176 has been evaluated in two completed Phase 1 trials. NCT04994743 was a safety, tolerability, and pharmacokinetic study in 16 healthy adults in the Netherlands. NCT04990310 was a single-dose absorption, distribution, metabolism, and excretion study of [14C]-CORT113176 in 6 healthy male participants in the United Kingdom.
Yes, [14C]-CORT113176 is an alternative name for CORT113176. The [14C] label denotes a carbon-14 radiolabeled version of the molecule used in the absorption, distribution, metabolism, and excretion study NCT04990310. Both names refer to the same investigational compound.