A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes
| Registry | NCT02497391 |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, crossover, masking: none, basic science |
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| Enrollment | 95 (Actual) |
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| Sponsor | Eli Lilly and Company (Industry) |
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| Conditions | Healthy |
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| Interventions | Evacetrapib (Drug) |
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| Dates | start 2015-07-01, primary completion 2015-11-01, completion 2015-11-01, first posted 2015-07-14, last updated 2018-12-03 |
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| Locations | 1 site in Singapore |
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-Summary
The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Evacetrapib Reference (R) | Experimental | Drug: Evacetrapib | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
| Evacetrapib Test 1 (T1) | Experimental | Drug: Evacetrapib | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
| Evacetrapib Test 2 (T2) | Experimental | Drug: Evacetrapib | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
- Evacetrapib (Drug), also known as LY2484595: administered orally
+Outcome measures
Primary outcomes
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib [Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose]
- PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib [Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose]
+Eligibility
Sex: All, ages: 21 Years to 65 Years, accepts healthy volunteers
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 allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.
+Posted results
Participant flow
| Milestone | Sequence 1 (R/T1/T2) | Sequence 2 (T1/T2/R) | Sequence 3 (T2/R/T1) | Sequence 4 (T2/T1/R) | Sequence 5 (R/T2/T1) | Sequence 6 (T1/R/T2) |
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| Started | 16 | 15 | 16 | 16 | 16 | 16 |
| Received at least 1 dose of study drug | 16 | 15 | 16 | 16 | 16 | 16 |
| Completed | 16 | 15 | 16 | 16 | 16 | 16 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Outcome results
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib (Primary), Geometric mean, nangram/milliliter (ng/mL): Evacetrapib Reference (R) 983 +/- 78; Evacetrapib Test 1 (T1) 1170 +/- 56; Evacetrapib Test 2 (T2) 1120 +/- 66
- PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Primary), Geometric mean, nanogram·hour/milliter (ng·h/mL): Evacetrapib Reference (R) 14700 +/- 53; Evacetrapib Test 1 (T1) 16100 +/- 45; Evacetrapib Test 2 (T2) 15500 +/- 49
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Evacetrapib Reference (R) | 0 | 0/84 (0.0%) | 33/84 (39.3%) |
| Evacetrapib Test 1 (T1) | 0 | 0/81 (0.0%) | 22/81 (27.2%) |
| Evacetrapib Test 2 (T2) | 0 | 0/85 (0.0%) | 23/85 (27.1%) |
Other adverse events by term
| Term | Organ system | Evacetrapib Reference (R) | Evacetrapib Test 1 (T1) | Evacetrapib Test 2 (T2) |
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| Catheter site related reaction | General disorders | 13/84 | 9/81 | 2/85 |
| Vessel puncture site bruise | General disorders | 16/84 | 12/81 | 20/85 |
| Headache | Nervous system disorders | 6/84 | 5/81 | 2/85 |
+Locations (1)
| Facility | City | Country | Status |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | Singapore | |
+Investigators
- 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), Study director, Eli Lilly and Company