Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03878264 | Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants | PHASE1 | COMPLETED | 12 | — | — | Aug 6, 2018 | Mar 24, 2019 | Jun 11, 2019 | 1 | United Kingdom |
| NCT03315338 | First-in-human Study in Healthy Subjects | PHASE1 | COMPLETED | 143 | — | — | Sep 15, 2017 | Feb 22, 2019 | May 24, 2019 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Age 18 to 65 years of age for Part 1 and 30 to 65 years of age for Part 2 * Body mass index of 18.0 to 30.0 kg/m\^2 * Provide written informed consent * Have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) for Part 2 * Adhere to the contrace...