Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505367-36-00 | Other Identifier | EU CT number | |
| J5B-MC-FHAF | Other Identifier | DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-DC-806 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-806 | Drug | Oral tablets |
| |
| [14C]-DC-806 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Clearance (CLr) of DC-806 | Day 1 to Day 11 | |
| CLr of Total Radioactivity | Day 1 to Day 11 | |
| Cumulative Amount Excreted in Urine (Aeurine) of DC-806 | Day 1 to Day 11 | |
| Aeurine of Total Radioactivity | Day 1 to Day 11 | |
| Percentage of the Dose Administered Excreted in Urine (Feurine) of DC-806 | Day 1 to Day 11 | |
| Feurine of Total Radioactivity | Day 1 to Day 11 | |
| Cumulative Amount Excreted in Feces (Aefeces) of Total Radioactivity | Day 1 to Day 11 | |
| Cumulative Amount Excreted in Vomitus (Aevomitus) of Total Radioactivity | Day 1 to Day 11 | |
| Percentage of the Dose Administered Excreted in Feces (Fefeces) of Total Radioactivity | Day 1 to Day 11 | |
| Percentage of the Dose Administered Excreted in Vomitus (Fevomitus) of Total Radioactivity | Day 1 to Day 11 | |
| Total Amount Excreted in Urine, Feces, and Vomitus (Aeurine + Aefeces + Aevomitus) of Total Radioactivity |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience an Adverse Event | Up to a maximum of 25 days | |
| Plasma, Whole Blood, Urine, and Feces Concentrations of DC-806 Major Metabolites | Day 1 to Day 11 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Phase 1 Clinic | Groningen | 9728 NZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral capsules |
|
| Day 1 to Day 11 |
| Total Percentage of the Dose Administered Excreted in Urine, Feces, and Vomitus (Feurine + Fefeces + Fevomitus) of Total Radioactivity | Day 1 to Day 11 |
| Maximum Observed Concentration (Cmax) of DC-806 in Whole Blood | Day 1 to Day 11 |
| Cmax of DC-806 in Plasma | Day 1 to Day 11 |
| Cmax of Total Radioactivity in Whole Blood | Day 1 to Day 11 |
| Cmax of Total Radioactivity in Plasma | Day 1 to Day 11 |
| Time to Cmax (tmax) of DC-806 in Whole Blood | Day 1 to Day 11 |
| tmax of DC-806 in Plasma | Day 1 to Day 11 |
| tmax of Total Radioactivity in Whole Blood | Day 1 to Day 11 |
| tmax of Total Radioactivity in Plasma | 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 | Day 1 to Day 11 |
| AUC0-t of DC-806 in Plasma | Day 1 to Day 11 |
| AUC0-t of Total Radioactivity in Whole Blood | Day 1 to Day 11 |
| AUC0-t of Total Radioactivity in Plasma | Day 1 to Day 11 |
| AUC from time 0 to infinity (AUC0-inf) of DC-806 in Whole Blood | Day 1 to Day 11 |
| AUC0-inf of DC-806 in Plasma | Day 1 to Day 11 |
| AUC0-inf of Total Radioactivity in Whole Blood | Day 1 to Day 11 |
| AUC0-inf of Total Radioactivity in Plasma | Day 1 to Day 11 |
| Apparent Terminal Elimination Rate Constant (λz) of DC-806 in Whole Blood | Day 1 to Day 11 |
| λz of DC-806 in Plasma | Day 1 to Day 11 |
| λz of Total Radioactivity in Whole Blood | Day 1 to Day 11 |
| λz of Total Radioactivity in Plasma | Day 1 to Day 11 |
| Apparent Terminal Elimination Half-life (t1/2) of DC-806 in Whole Blood | Day 1 to Day 11 |
| t1/2 of DC-806 in Plasma | Day 1 to Day 11 |
| t1/2 of Total Radioactivity in Whole Blood | Day 1 to Day 11 |
| t1/2 of Total Radioactivity in Plasma | Day 1 to Day 11 |
| Apparent Total Clearance (CL/F) of DC-806 in Whole Blood | Day 1 to Day 11 |
| CL/F of DC-806 in Plasma | Day 1 to Day 11 |
| Apparent Volume of Clearance (Vz/F) of DC-806 in Whole Blood | Day 1 to Day 11 |
| Vz/F of DC-806 in Plasma | Day 1 to Day 11 |
| Cmax of Total Radioactivity Blood to Plasma Ratio | Day 1 to Day 11 |
| AUC0-inf of Total Radioactivity Blood to Plasma Ratio | Day 1 to Day 11 |