Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy participants. It is currently in Phase 1 clinical development, with completed trials evaluating its safety, tolerability, and pharmacokinetics in healthy male, Japanese, Caucasian, and other healthy adult participants. It is not approved for any condition.
LY3337641 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company has sponsored multiple Phase 1 clinical trials of this investigational small molecule in healthy participants.
LY3337641 is in Phase 1 clinical development. All three of its clinical trials, which enrolled a total of 71 healthy participants, have been completed. The drug remains investigational and has not been approved by regulatory authorities.
LY3337641 has been studied in three completed Phase 1 trials: NCT02914379 in healthy male participants in the United States, NCT03083561 in Japanese and Caucasian healthy participants in the United States, and NCT03099148 in healthy participants in Singapore. All trials were randomized, double-blind, and placebo-controlled.
LY3337641 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in healthy participants. These trials were designed to assess safety and tolerability, but the drug has not progressed to later-stage trials or received marketing approval.