Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001700-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-CORT125281 in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Experimental | On Day 1, participants will receive a single oral dose of 14C-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-CORT125281 | Drug | 14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281 | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281 | Until the mass balance criteria for all participants have been met (estimated up to 10 days) | |
| Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281 | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax) | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (tmax) | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma 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 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2) | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT) | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: Cmax | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: tmax | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: AUC0-last | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: t1/2 | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: MRT | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
| Percentage of Participants with One or More Adverse Events | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |