The primary objective of this study is to investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of DC-806 containing 3.7 MBq (100 μCi) of \[14C\]-DC-806 in urine and feces.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral tablets
Oral capsules
ICON Phase 1 Clinic
Groningen, Netherlands
Renal Clearance (CLr) of DC-806
Time frame: Day 1 to Day 11
CLr of Total Radioactivity
Time frame: Day 1 to Day 11
Cumulative Amount Excreted in Urine (Aeurine) of DC-806
Time frame: Day 1 to Day 11
Aeurine of Total Radioactivity
Time frame: Day 1 to Day 11
Percentage of the Dose Administered Excreted in Urine (Feurine) of DC-806
Time frame: Day 1 to Day 11
Feurine of Total Radioactivity
Time frame: Day 1 to Day 11
Cumulative Amount Excreted in Feces (Aefeces) of Total Radioactivity
Time frame: Day 1 to Day 11
Cumulative Amount Excreted in Vomitus (Aevomitus) of Total Radioactivity
Time frame: Day 1 to Day 11
Percentage of the Dose Administered Excreted in Feces (Fefeces) of Total Radioactivity
Time frame: Day 1 to Day 11
Percentage of the Dose Administered Excreted in Vomitus (Fevomitus) of Total Radioactivity
Time frame: Day 1 to Day 11
Total Amount Excreted in Urine, Feces, and Vomitus (Aeurine + Aefeces + Aevomitus) of Total Radioactivity
Time frame: Day 1 to Day 11
Total Percentage of the Dose Administered Excreted in Urine, Feces, and Vomitus (Feurine + Fefeces + Fevomitus) of Total Radioactivity
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Time frame: Day 1 to Day 11
Maximum Observed Concentration (Cmax) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
Cmax of DC-806 in Plasma
Time frame: Day 1 to Day 11
Cmax of Total Radioactivity in Whole Blood
Time frame: Day 1 to Day 11
Cmax of Total Radioactivity in Plasma
Time frame: Day 1 to Day 11
Time to Cmax (tmax) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
tmax of DC-806 in Plasma
Time frame: Day 1 to Day 11
tmax of Total Radioactivity in Whole Blood
Time frame: Day 1 to Day 11
tmax of Total Radioactivity in Plasma
Time frame: Day 1 to Day 11
Area Under the Concentration-time Curve (AUC) up to Time t, where t is the Last Point with Concentrations Above the Lower Limit of Quantification (AUC0-t) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
AUC0-t of DC-806 in Plasma
Time frame: Day 1 to Day 11
AUC0-t of Total Radioactivity in Whole Blood
Time frame: Day 1 to Day 11
AUC0-t of Total Radioactivity in Plasma
Time frame: Day 1 to Day 11
AUC from time 0 to infinity (AUC0-inf) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
AUC0-inf of DC-806 in Plasma
Time frame: Day 1 to Day 11
AUC0-inf of Total Radioactivity in Whole Blood
Time frame: Day 1 to Day 11
AUC0-inf of Total Radioactivity in Plasma
Time frame: Day 1 to Day 11
Apparent Terminal Elimination Rate Constant (λz) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
λz of DC-806 in Plasma
Time frame: Day 1 to Day 11
λz of Total Radioactivity in Whole Blood
Time frame: Day 1 to Day 11
λz of Total Radioactivity in Plasma
Time frame: Day 1 to Day 11
Apparent Terminal Elimination Half-life (t1/2) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
t1/2 of DC-806 in Plasma
Time frame: Day 1 to Day 11
t1/2 of Total Radioactivity in Whole Blood
Time frame: Day 1 to Day 11
t1/2 of Total Radioactivity in Plasma
Time frame: Day 1 to Day 11
Apparent Total Clearance (CL/F) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
CL/F of DC-806 in Plasma
Time frame: Day 1 to Day 11
Apparent Volume of Clearance (Vz/F) of DC-806 in Whole Blood
Time frame: Day 1 to Day 11
Vz/F of DC-806 in Plasma
Time frame: Day 1 to Day 11
Cmax of Total Radioactivity Blood to Plasma Ratio
Time frame: Day 1 to Day 11
AUC0-inf of Total Radioactivity Blood to Plasma Ratio
Time frame: Day 1 to Day 11
Number of Participants who Experience an Adverse Event
Time frame: Up to a maximum of 25 days
Plasma, Whole Blood, Urine, and Feces Concentrations of DC-806 Major Metabolites
Time frame: Day 1 to Day 11