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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
Time frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281
Time frame: 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
Time frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
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Plasma PK of CORT125281 after Oral Dosing: Cmax
Time frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: tmax
Time frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: AUC0-last
Time frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: t1/2
Time frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: MRT
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)