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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001507-36 | EudraCT Number |
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This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Part 2 | Experimental | On Day 1, participants will receive a single oral dose of 14C-CORT118335 150 mg (Treatment C) after an overnight fast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORT118335 Oral | Drug | CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Oral Bioavailability (F) of CORT118335 | Predose and at pre-specified time points up to Day 12 | |
| Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT118335 | Until the mass balance criteria have been met by all participants (estimated Day 17) | |
| Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT118335 | Until the mass balance criteria have been met by all participants (estimated Day 17) | |
| Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT118335 | Until the mass balance criteria have been met by all participants (estimated Day 17) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax) | Pre-dose and at pre-specified time points up to Day 15 after dosing | |
| PK of Total Radioactivity in Plasma after Oral Dosing: Time from Dosing to Cmax (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sharan Sidhu, MBChB, BAO, MRCS, MFPM | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C000606526 | CORT118335 |
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| 14C-CORT118335 intravenous | Drug | 14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C |
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| 14C-CORT118335 oral | Drug | 14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C |
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| Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Total Radioactivity after Oral Dosing: Area Under the Plasma Concentration-time Curve from Zero Time to Time of the Last Measurable Concentration (AUC0-last) | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Total Radioactivity in Plasma after Oral Dosing: Apparent Elimination Half-life (t1/2) | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Total Radioactivity in Plasma after Oral Dosing: Mean Residence Time (MRT) | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Plasma CORT118335 after Oral Dosing: Cmax | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Plasma CORT118335 after Oral Dosing: Tmax | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Plasma CORT118335 after Oral Dosing: AUC0-last | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Plasma CORT118335 after Oral Dosing: MRT | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| PK of Plasma 14C-CORT118335 after IV Dosing: Cmax | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Plasma 14C-CORT118335 after IV Dosing: AUC0-last | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Plasma 14C-CORT118335 after IV Dosing: t1/2 | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Plasma 14C-CORT118335 after IV Dosing: Total Clearance (CL) | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Plasma 14C-CORT118335 after IV Dosing: MRT | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Total Radioactivity in Plasma after IV Dosing: Cmax | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Total Radioactivity in Plasma after IV Dosing: AUC0-last | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Total Radioactivity in Plasma after IV Dosing: t1/2 | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Total Radioactivity in Plasma after IV Dosing: CL | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK of Total Radioactivity in Plasma after IV Dosing: MRT | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| PK in Plasma after IV Dosing: AUC0-last for 14C-CORT118335 / AUC0-last for Total Radioactivity | Pre-dose and at pre-specified time points up to Day 12 after dosing |
| Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing | Pre-dose and at pre-specified time points up to Day 15 after dosing |
| Number of CORT118335 Metabolites Accounting for >10% of Total Radioactivity Detected in Plasma, Urine, and Feces | Until the mass balance criteria have been met by all participants (estimated Day 17) |
| Percentage of Participants with One or More Adverse Events | Until the mass balance criteria have been met by all participants (estimated Day 17) |