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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
\[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.
Site 01
Ruddington, Nottingham, United Kingdom
Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176
Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176
Time frame: 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
Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
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Plasma PK of CORT113176 after Oral Dosing: Cmax
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: Tmax
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: AUC0-last
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: t1/2
Time frame: 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
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
Number of Participants with One or More Adverse Events
Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)