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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002544-78 | EudraCT Number |
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This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of [14C]-CORT113176 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-CORT113176 | Drug | [14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176 | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176 | Until the mass balance criteria for all participants have been met (estimated up to 28 days) | |
| Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176 | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazel Hunt, Ph.D. | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
| Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax) | Before dosing 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) | Before dosing 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) | Before dosing 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) | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT113176 after Oral Dosing: Cmax | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT113176 after Oral Dosing: Tmax | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT113176 after Oral Dosing: AUC0-last | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT113176 after Oral Dosing: t1/2 | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Number of Participants with One or More Adverse Events | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |