Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03099148 | A Study of LY3337641 in Healthy Participants | PHASE1 | COMPLETED | 29 | — | — | Apr 4, 2017 | May 31, 2017 | Oct 17, 2023 | 2 | Singapore |
| NCT03083561 | A Study of LY3337641 in Japanese and Caucasian Healthy Participants | PHASE1 | COMPLETED | 36 | — | — | Mar 15, 2017 | May 25, 2017 | Aug 25, 2023 | 1 | United States |
| NCT02914379 | A Study of LY3337641 in Healthy Male Participants | PHASE1 | COMPLETED | 6 | — | — | Sep 1, 2016 | Nov 1, 2016 | Aug 25, 2023 | 1 | United States |
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...