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| ID | Type | Description | Link |
|---|---|---|---|
| J4G-OX-JZVB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how much of the study drug (LY3866288), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study will also evaluate the safety and tolerability of LY3866288.The study is conducted in two parts. The study is expected to last approximately 68 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: [14C]-LY3866288 | Experimental | Single dose of [¹⁴C]-LY3866288 administered orally. |
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| Part B: LY3866288 + [14C]-LY3866288 | Experimental | Single dose of LY3866288 administered orally followed by a single dose of [¹⁴C]-LY3866288 administered intravenously (IV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-LY3866288 | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 postdose | |
| Part A, Fraction of Dose [14C]-LY3866288 Excreted in Feces Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 postdose | |
| Part B, Absolute Bioavailability (Fabs) of LY3866288 | Predose up to Day 9 postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 7 postdose | |
| Part A: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma and Whole Blood Following a Single Oral Dose of [14C]-LY3866288 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| LY3866288 |
| Drug |
Administered orally. |
|
| [14C]-LY3866288 | Drug | Administered IV. |
|
| Predose up to Day 21 postdose |
| Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 7 postdose |
| Part A: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 21 postdose |
| Part A: PK: Ratio of AUC0-inf of Plasma LY3866288 to AUC0-inf of Plasma Total Radioactivity | Predose up to Day 21 postdose |
| Part A: PK: Ratio of AUC0-inf of Whole Blood Total Radioactivity to AUC0-inf of Plasma Total Radioactivity | Predose up to Day 21 postdose |
| Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of [14C]-LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Maximum Observed Plasma Concentration (Cmax) of [14C]-LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma | Predose up to Day 9 postdose |