Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Evacetrapib · 16 trials · 5 indications
Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.
Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.
Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.
Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).
Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.
Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin. Tmax of simvastatin and atorvastatin.
The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).
Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC\[0-∞\]) is summarized for each solid fraction control (Reference and Test).
tlast is defined as the last time point with a measurable concentration of Evacetrapib.
Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil.
| Arm | Type | Description |
|---|---|---|
| Evacetrapib Reference (R) | EXPERIMENTAL | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
| Evacetrapib Test 1 (T1) | EXPERIMENTAL | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
| Evacetrapib Test 2 (T2) | EXPERIMENTAL | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
| Evacetrapib | EXPERIMENTAL | Single oral dose of evacetrapib administered alone on Day 1 of Period 1. |
| Omeprazole + Evacetrapib | EXPERIMENTAL | In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be co-administered once, orally on Day 14. |
| Evacetrapib Tablet + Evacetrapib Intravenous | EXPERIMENTAL | A single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)\[¹³C₈\] evacetrapib administered over a 4 hour infusion. |
| Evacetrapib (reference) | EXPERIMENTAL | Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods |
| Evacetrapib (test) | EXPERIMENTAL | Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods |
| Evacetrapib Single | EXPERIMENTAL | Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib. |
| Evacetrapib Multiple | EXPERIMENTAL | Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days. |
| Simvastatin | ACTIVE_COMPARATOR | Part 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4. |
| Evacetrapib and Simvastatin | EXPERIMENTAL | Part 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22. |
| Atorvastatin | ACTIVE_COMPARATOR | Part 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4. |
| Evacetrapib and Atorvastatin | EXPERIMENTAL | Part 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22. |
| Warfarin | ACTIVE_COMPARATOR | 15 milligram (mg) warfarin administered as a single oral dose on Day 1 |
| Evacetrapib + Warfarin | EXPERIMENTAL | Evacetrapib administered once daily (QD), orally, for 16 days with 15 mg warfarin co-administered once orally on Day 17 |
| Evacetrapib: Single Dose | EXPERIMENTAL | Single oral dose of evacetrapib on Day 1 |
| Evacetrapib: Multiple Dose 12 Weeks | EXPERIMENTAL | Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks |
| Evacetrapib: Multiple Dose 24 Weeks | EXPERIMENTAL | Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks |
| Evacetrapib: Multiple Dose 52 Weeks | EXPERIMENTAL | Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks |
| Pravastatin | EXPERIMENTAL | Single 40 milligram (mg) oral dose of pravastatin administered on Day 1. |
| Evacetrapib + Pravastatin | EXPERIMENTAL | Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11. |
| Digoxin | ACTIVE_COMPARATOR | 0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1 |
| Evacetrapib + Digoxin | EXPERIMENTAL | 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15 |
| Evacetrapib -- Solid Fraction Test | EXPERIMENTAL | Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods |
| Evacetrapib -- Solid Fraction Reference | EXPERIMENTAL | Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods |
| Evacetrapib + Rifampin | EXPERIMENTAL | Period 2: Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22) Evacetrapib: 130 mg administered orally once on Day 16 |
| Evacetrapib (Participants With Renal Impairment) | EXPERIMENTAL | Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment. |
| Evacetrapib (Healthy Participants) | EXPERIMENTAL | Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function. |
| Evacetrapib (Healthy) | EXPERIMENTAL | Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function |
| Evacetrapib (Hepatic, Mild) | EXPERIMENTAL | Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment |
| Evacetrapib (Hepatic, Moderate) | EXPERIMENTAL | Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment |
| Evacetrapib (Hepatic, Severe) | EXPERIMENTAL | Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment |
| Evacetrapib (Fasted) | EXPERIMENTAL | 130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days. |
| Evacetrapib (Fed) | EXPERIMENTAL | 130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days. |
| Gemfibrozil | EXPERIMENTAL | Single oral dose of 600 milligrams (mg) gemfibrozil on Day 1 |
| Evacetrapib + Gemfibrozil | EXPERIMENTAL | Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23. |
| Name | Type | Description |
|---|---|---|
| Evacetrapib | DRUG | administered orally |
| Omeprazole | DRUG | Administered orally |
| Evacetrapib Tablet | DRUG | Oral administration |
| Evacetrapib Intravenous | DRUG | Intravenous administration |
| Simvastatin | DRUG | Administered orally. |
| Atorvastatin | DRUG | Administered orally. |
| Warfarin | DRUG | Oral administration |
| Pravastatin | DRUG | Administered orally |
| Digoxin | DRUG | Administered orally |
| Rifampin | DRUG | Administered orally |
| High-fat Meal | OTHER | Administered orally, at breakfast. |
| Gemfibrozil | DRUG | - |
Inclusion Criteria: * Overtly healthy participants of non-child bearing potential * Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2) * Must be willing to make oneself available for the whole study and be willing to follow study procedures Exclusion Criteria: * Have known al...
Evacetrapib is an investigational small molecule being studied in healthy volunteers, in people with hepatic insufficiency, and in conditions including dyslipidemia and cardiovascular disease. It is being developed by Eli Lilly and Company. Evacetrapib is not approved and remains in clinical development.
Evacetrapib is a small molecule that targets cholesteryl ester transfer protein (CETP). By inhibiting CETP, it is intended to affect lipid metabolism, which is relevant to dyslipidemia and cardiovascular disease. The drug is being developed by Eli Lilly and Company.
Eli Lilly and Company (NYSE: LLY) is developing Evacetrapib. The drug is an investigational small molecule being studied for dyslipidemia, cardiovascular disease, hepatic insufficiency, and in healthy volunteers. It is not approved and remains in clinical development.
Evacetrapib is in Phase 1 clinical development. All 11 trials listed for the drug are completed, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
Evacetrapib has completed Phase 1 trials including NCT01810432, a food effect study in healthy participants; NCT02161731, a drug interaction study with warfarin; NCT02365558, a study on stomach pH effects; and NCT02497391, a study of different particle sizes. All trials are completed.
Yes, Evacetrapib is also known as LY2484595. Clinical trial titles reference both names, such as NCT01810432, which is titled 'Study of Food on Evacetrapib (LY2484595) in Healthy Participants.' The drug is being developed by Eli Lilly and Company.