A Phase 1 interventional study of DC-806 and [14C]-DC-806 in Healthy Volunteers, sponsored by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single oral dose of unlabeled DC-806 tablets followed by DC-806 capsule containing 3.7 MBq (100 μCi) of \[14C\]-DC-806 on Day 1.
Drug: DC-806 · Drug: [14C]-DC-806
Oral tablets
Oral capsules
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
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
Plan to share: No
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DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company