Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [¹⁴C]-LY3337641, LY3337641 (T1)
LY3337641 · 3 trials · 1 indication
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.
Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.
| Arm | Type | Description |
|---|---|---|
| LY3337641 (R-fasted) | EXPERIMENTAL | A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods. |
| LY3337641 (T1-fasted) | EXPERIMENTAL | A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods. |
| LY3337641 (T1-fed) | EXPERIMENTAL | A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods. |
| LY3337641 (T2-fasted) | EXPERIMENTAL | A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods. |
| LY3337641 Multiple Dose | EXPERIMENTAL | Multiple doses of 30 mg LY3337641 tablet administered orally every day for two weeks, with a two week follow-up period. |
| Placebo Multiple Dose | PLACEBO_COMPARATOR | Multiple doses of placebo administered orally every day for two weeks, with a two week follow-up period. |
| LY3337641 Single Dose | EXPERIMENTAL | Single dose of 5 mg, 80 mg and 160 mg LY3337641 tablet administered orally, with a two week follow-up period. |
| Placebo Single Dose | PLACEBO_COMPARATOR | Single dose of placebo administered orally, with a two week follow-up period. |
| 20mg [¹⁴C]-LY3337641 | EXPERIMENTAL | Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity. |
| Name | Type | Description |
|---|---|---|
| Reference Formulation (R) | DRUG | Administered PO |
| LY3337641 (T1) | DRUG | 20 mg PO |
| LY3337641 (T2) | DRUG | 20 mg PO |
| LY3337641 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| [¹⁴C]-LY3337641 | DRUG | Administered orally |
Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive * Have clinical laboratory test results within normal reference range for the population o...
LY3337641 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in Phase 1 clinical trials in healthy participants rather than in patients with a specific disease. No therapeutic indication for LY3337641 has been disclosed.
LY3337641 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 studies conducted with the compound.
LY3337641 is in Phase 1 development. All three of its clinical trials are Phase 1 studies and all three are completed, with no active trials ongoing. The compound is investigational and has not been approved by the FDA.
LY3337641 has been evaluated in three completed Phase 1 trials: NCT03099148 in 29 healthy participants in Singapore, NCT03083561 in 36 Japanese and Caucasian healthy participants in the United States, and NCT02914379 in 6 healthy male participants in the United States. Total enrollment across the three studies was 71 participants.
Yes. [14C]-LY3337641 is an alternative name for LY3337641, referring to a carbon-14 radiolabeled form of the compound used in study work. LY3337641 (T1) is another listed alternate name. All refer to the same Eli Lilly small molecule.
The LY3337641 Phase 1 trials were randomized, double-blind, and placebo-controlled, and they enrolled healthy volunteers rather than patients. The studies were conducted in Singapore and the United States, and all three have been completed.