Approval Probability
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Adjusted LOA
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CORT118335 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Olanzapine plus CORT118335 | EXPERIMENTAL | Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days. |
| Olanzapine plus Placebo | PLACEBO_COMPARATOR | Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days. |
| Part 1 | EXPERIMENTAL | On Day 1, participants will receive a single oral dose of CORT118335 900 mg (Treatment A) after an overnight fast, and a 15-minute intravenous infusion of a microdose of 14C-CORT118335 (Treatment B) beginning 2 hours 45 minutes after the oral dose is administered. |
| Part 2 | EXPERIMENTAL | On Day 1, participants will receive a single oral dose of 14C-CORT118335 150 mg (Treatment C) after an overnight fast. |
| SAD Part 1 Active Cohort A | EXPERIMENTAL | CORT118335, 25 mg |
| SAD Part 1 Placebo oral capsule Cohort A | PLACEBO_COMPARATOR | - |
| SAD Part 1 Active Cohort B | EXPERIMENTAL | CORT118335, 75mg |
| SAD Part 1 Placebo Cohort B | PLACEBO_COMPARATOR | - |
| SAD Part 1 Active Cohort C | EXPERIMENTAL | CORT118335, 225mg |
| SAD Part 1 Placebo Cohort C | PLACEBO_COMPARATOR | - |
| SAD Part 1 Active Cohort D | EXPERIMENTAL | CORT118335, 675mg |
| SAD Part 1 Placebo Cohort D | PLACEBO_COMPARATOR | - |
| SAD Part 2 Active Cohort A, Fasting | EXPERIMENTAL | CORT118335, 600mg, is supplied as capsules for oral dosing given after an overnight fast |
| SAD Part 2 Active Cohort A, Fed | EXPERIMENTAL | CORT118335, 600mg, is supplied as capsules for oral dosing given after a high-fat breakfast |
| SAD Part 2 Placebo PD Effect Cohort B | PLACEBO_COMPARATOR | - |
| SAD Part 2 Active PD Effect Cohort B: 630mg of CORT118335 | EXPERIMENTAL | - |
| SAD Part 2 Active PD Effect Cohort B: 675mg of CORT118335 | EXPERIMENTAL | - |
| MAD Part 3 Active Cohort A | EXPERIMENTAL | CORT118335, 375mg qd for 14 days |
| MAD Part 3 Placebo Cohort A | PLACEBO_COMPARATOR | Placebo qd for 14 days |
| SAD Part 4 Active Cohort A | EXPERIMENTAL | CORT118335, 100mg |
| SAD Part 4 Placebo Cohort A | PLACEBO_COMPARATOR | - |
| SAD Part 4 Active Cohort B | EXPERIMENTAL | CORT118335, 300mg |
| SAD Part 4 Placebo Cohort B | PLACEBO_COMPARATOR | - |
| SAD Part 4 Active Cohort C, Fasting | EXPERIMENTAL | CORT118335, 900mg is supplied as suspension for oral dosing given after an overnight fast |
| SAD Part 4 Active Cohort C, Fed | EXPERIMENTAL | CORT118335, 900mg is supplied as suspension for oral dosing given after a high-fat breakfast |
| SAD Part 4 Placebo Cohort C, Fasting | PLACEBO_COMPARATOR | Supplied as suspension for oral dosing given after an overnight fast |
| SAD Part 4 Placebo Cohort C, Fed | PLACEBO_COMPARATOR | Supplied as suspension for oral dosing given after a high-fat breakfast |
| SAD Part 4 Active Cohort Part D | EXPERIMENTAL | CORT118335, 1500mg |
| SAD Part 4 Placebo Cohort D | PLACEBO_COMPARATOR | - |
| MAD Part 5 Active Cohort A | EXPERIMENTAL | CORT118335, 150mg |
| MAD Part 5 Placebo Cohort A | PLACEBO_COMPARATOR | - |
| MAD Part 5 Active Cohort B | EXPERIMENTAL | CORT118335, dose to be determined |
| MAD Part 5 Placebo Cohort B | PLACEBO_COMPARATOR | - |
| MAD Part 5 Active Cohort C | EXPERIMENTAL | CORT118335, dose to be determined |
| MAD Part 5 Placebo Cohort C | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Olanzapine | DRUG | Olanzapine 10 mg oral tablet |
| CORT118335 | DRUG | CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets |
| Placebo | DRUG | Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available |
| CORT118335 Oral | DRUG | CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration |
| 14C-CORT118335 intravenous | DRUG | 14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C |
| 14C-CORT118335 oral | DRUG | 14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C |
| CORT118335, 25 mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| Prednisone Oral Tablet | DRUG | Challenge Agent, Dose and Route of Administration: Standard release 1x20mg and 1x5mg (25mg total) dose, orally administered. |
| Glucose | DRUG | 75 g in 300 mL solution, orally administered |
| Placebo oral suspension | DRUG | Reference Therapy, Dose and Route of Administration: Placebo suspension, orally administered. |
| CORT118335, 75mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| CORT118335, 225mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| CORT118335, 675mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| CORT118335, 600mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| CORT118335, 630mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| CORT118335, 375mg | DRUG | CORT118335 is supplied as capsules for oral dosing |
| CORT118335, 100mg | DRUG | CORT118335 is supplied as a suspension for oral dosing |
| CORT118335, 300mg | DRUG | CORT118335 is supplied as a suspension for oral dosing |
| CORT118335, 900mg | DRUG | CORT118335 is supplied as a suspension for oral dosing |
| CORT118335, 150mg | DRUG | CORT118335 is supplied as a suspension for oral dosing |
| CORT118335, 1500mg | DRUG | CORT118335 is supplied as a suspension for oral dosing |
| Placebo oral capsule | DRUG | Placebo capsules, orally administered |
| CORT118335, dose to be determined | DRUG | CORT118335 is supplied as suspension for oral dosing |
Inclusion Criteria: * Body mass index 18.0 to 25.0 kg/m\^2, inclusive * Stable body weight as indicated by assessment at screening and pre-dose * Able to swallow the size and number of tablets required * Provide written informed consent and agree to adhere to study restrictions and contraception re...
CORT118335 is an investigational small molecule being studied for antipsychotic-induced weight gain and in healthy volunteers. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its potential to address weight gain associated with antipsychotic medications.
CORT118335 is being developed by Corcept Therapeutics Incorporated, a company traded on the NASDAQ under the ticker symbol CORT. The drug is currently in Phase 1 clinical development for antipsychotic-induced weight gain and has completed early-stage trials in healthy volunteers.
CORT118335 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. Two Phase 1 trials have been completed, including a first-in-human study and a study evaluating its effect on olanzapine-induced weight gain.
CORT118335 has completed three Phase 1 trials. NCT03315338 was a first-in-human study in healthy subjects with 143 participants. NCT03877562 evaluated the drug's effect on olanzapine-induced weight gain in 96 healthy males. NCT03878264 studied absolute bioavailability and metabolism in 12 healthy male participants.
CORT118335 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed early-stage trials in healthy volunteers and for antipsychotic-induced weight gain, but it has not yet progressed to later-stage trials or received marketing authorization.