Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J5C-MC-FOAE | 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
Not provided
The study has two parts, Part A and Part B. The purpose of Part A is to determine the absorption, metabolism, and excretion (AME) of [14C]-LY4100511 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants after a single oral dose of LY4100511. The purpose of Part B is to determine the absolute bioavailability of LY4100511 in humans, to further analyze the rate and routes of excretion, including the mass balance, and to further investigate the pharmacokinetics (PK) of [14C]-LY4100511, LY4100511, and TRA.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A LY4100511 (tablet formulation) and [14C]-LY4100511 capsule | Experimental | Participants will receive a single oral dose 1 or dose 2 unlabeled LY4100511 (tablet formulation) administered with a dose 1 [14C]-LY4100511 capsule containing approximately 100 µCi (3.7 MBq) of radioactivity in the fasted state |
|
| Part B LY4100511 (tablet formulation) and [14C]-LY4100511 | Experimental | Participants will receive a single oral dose 1 or dose 2 unlabeled LY4100511 (tablet formulation) in the fasted state, followed by a single intravenous (IV) dose of of [14C]-LY4100511, containing ≤1 μCi (≤37 kBq) of radioactivity, administered as an infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4100511 (DC-853) | Drug | Administered oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Total Radioactivity Recovery and Excretion (TRA) | Total radioactivity recovery and excretion (fet1-t2 and Aet1-t2) in urine and feces (and vomitus, if available) | Up until Day 15 |
| Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for [14C] LY4100511 | Up until Day 15 | |
| Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for LY4100511 | Up until Day 15 | |
| Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for TRA | Up until Day 15 | |
| Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for [14C] LY4100511 | Up until Day 15 | |
| Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for LY4100511 | Up until Day 15 | |
| Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for TRA | Up until Day 15 | |
| Part A: PK Maximum Observed Plasma Concentration (Cmax) for [14C] LY4100511 | Up until Day 15 | |
| Part A: PK Maximum Observed Plasma Concentration (Cmax) for LY4100511 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Adverse Events (AEs), and Serious Adverse Events (SAEs) considered by the investigator to be related to study drug administration | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events Module. | Up until Day 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Have a 12-lead ECG abnormality that, in the opinion of the Investigator
Have a current or recent acute, active infection (for example, for at least 30 days before screening and up to check-in, participants must have no symptoms or signs of infection in the absence of any anti-infective treatment).
Had any malignancy within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline.
Are immunocompromised.
Have inflammatory bowel disease (IBD)
individuals assigned male at birth
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| [14C]-LY4100511 (DC-853) Administered oral dose | Drug | Administered oral dose |
|
| LY4100511 (DC-853) | Drug | Administered oral dose |
|
| [14C]-LY4100511 (DC-853) | Drug | Administered IV infusion |
|
| Up until Day 15 |
| Part A: PK Maximum Observed Plasma Concentration (Cmax) for TRA | Up until Day 15 |
| Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for [14C] LY4100511 | Up until Day 15 |
| Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for LY4100511 | Up until Day 15 |
| Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for TRA | Up until Day 15 |
| Part A: PK Terminal Elimination Half Life (t1/2) for [14C] LY4100511 | Up until Day 15 |
| Part A: PK Terminal Elimination Half Life (t1/2) for LY4100511 | Up until Day 15 |
| Part A: PK Terminal Elimination Half Life (t1/2) for TRA | Up until Day 15 |
| Part A: Urinary Recovery and Excretion of TRA (Aet1-t2) | Up until Day 15 |
| Part A: Urinary Recovery and Excretion of [14C] LY4100511 (Aet1-t2) | Up until Day 15 |
| Part A: Renal clearance of [14C] LY4100511 (CLR) | Up until Day 15 |
| Part B: Pharmacokinetic (PK): absolute bioavailability (Fabs) of LY4100511 | Up until Day 6 |
| Part B: Recovery of TRA in urine and feces | Up until Day 6 |
| Part B: Recovery of [14C]-LY4100511 in feces (Aet1-t2) following IV dosing | Up until Day 6 |
| Part B: Recovery of [14C]-LY4100511 in urine (Aet1-t2) following IV dosing | Up until Day 6 |
| Part B: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) of LY4100511 following IV dosing | Up until Day 6 |
| Part B: PK Maximum Observed Plasma Concentration (Cmax) of LY4100511following IV dosing | Up until Day 6 |
| Part B: PK Time to Maximum Observed Plasma Concentration (tmax) of LY4100511following IV dosing | Up until Day 6 |
| Part B: PK Terminal Elimination Half Life (t1/2) following IV dosing | Up until Day 6 |
| Part B: PK Clearance (CL) following IV dosing | Up until Day 6 |
| Part B: PK renal clearance (CLr) following IV dosing [Time Frame: Up until Day 6] | Up until Day 6 |