A Phase 1 interventional study of LY2484595 Reference Formulation (RF) and LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG) in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects, and first-generation Japanese subjects after receiving a single oral dose of LY2484595 in a fasted state, after eating a low-fat meal, and after eating a high-fat meal.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LY2484595 (evacetrapib): 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast.
Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
LY2484595 (evacetrapib): 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
Drug: LY2484595 Reference Formulation (RF) · Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Administered orally
Also known as: Evacetrapib
Administered orally
Also known as: Evacetrapib
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595
Area under the concentration-time curve from time zero to infinity is presented.
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose
Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
Data presented are the number of participants who experienced one or more drug-related AEs or any serious AEs. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline through completion of study (approximately 2 months)
| Milestone | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments |
|---|---|---|
| Started | 8 | 31 |
| Received at least 1 dose of study drug | 8 | 31 |
| Completed | 8 | 31 |
| Not completed | 0 | 0 |
| Milestone | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments |
|---|---|---|
| Started | 8 | 31 |
| Completed | 8 | 31 |
| Not completed | 0 | 0 |
| Milestone | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments |
|---|---|---|
| Started | 8 | 31 |
| Received at least 1 dose of study drug | 8 | 31 |
| Completed | 8 | 31 |
| Not completed | 0 | 0 |
| Milestone | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments |
|---|---|---|
| Started | 8 | 31 |
| Completed | 8 | 31 |
| Not completed | 0 | 0 |
| Milestone | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments |
|---|---|---|
| Started | 8 | 31 |
| Received at least 1 dose of study drug | 8 | 30 |
| Completed | 8 | 28 |
| Not completed | 0 | 3 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Area under the concentration-time curve from time zero to infinity is presented.
| hours times nanograms per milliliter | LY2484595 200 mg SDSD-PG Fasted | LY2484595 200 mg SDSD-PG Low Fat | LY2484595 200 mg SDSD-PG High Fat |
|---|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595 | 12200 ± 29 | 17800 ± 31 | 17800 ± 29 |
| nanograms per milliliter | LY2484595 200 mg SDSD-PG Fasted | LY2484595 200 mg SDSD-PG Low Fat | LY2484595 200 mg SDSD-PG High Fat |
|---|---|---|---|
| Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595 | 828 ± 51 | 1510 ± 30 | 1280 ± 28 |
Data presented are the number of participants who experienced one or more drug-related AEs or any serious AEs. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
| participants | LY2484595 100 mg RF | LY2484595 100 mg SDSD-PG | LY2484595 200 mg SDSD-PG | LY2484595 300 mg SDSD-PG |
|---|---|---|---|---|
| Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | 0 | 0 | 2 | 1 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2484595 100 mg RF | — | 0/30 (0%) | 0/30 (0%) |
| LY2484595 100 mg SDSD-PG | — | 0/30 (0%) | 0/30 (0%) |
| LY2484595 200 mg SDSD-PG | — | 0/8 (0%) | 3/8 (37.5%) |
| LY2484595 300 mg SDSD-PG | — | 0/31 (0%) | 4/31 (12.9%) |
| Event | LY2484595 100 mg RF | LY2484595 100 mg SDSD-PG | LY2484595 200 mg SDSD-PG | LY2484595 300 mg SDSD-PG |
|---|---|---|---|---|
| FlatulenceGastrointestinal disorders | 0/30 | 0/30 | 1/8 | 0/31 |
| HeadacheNervous system disorders | 0/30 | 0/30 | 1/8 | 0/31 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/30 | 0/30 | 1/8 | 0/31 |
| Aphthous stomatitisGastrointestinal disorders | 0/30 | 0/30 | 0/8 | 1/31 |
| GastroenteritisInfections and infestations | 0/30 | 0/30 | 0/8 | 1/31 |
| Transaminases increasedInvestigations | 0/30 | 0/30 | 0/8 | 1/31 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/30 | 0/30 | 0/8 | 1/31 |
| RashSkin and subcutaneous tissue disorders | 0/30 | 0/30 | 0/8 | 1/31 |
All participants who received at least 1 dose of study drug
| Age, Continuous(years) | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments | Total |
|---|---|---|---|
| Mean | 32.0 ± 6.2 | 37.3 ± 11.4 | 36.2 ± 10.73 |
| Sex: Female, Male(Participants) | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments | Total |
|---|---|---|---|
| Female | 0 | 6 | 6 |
| Male | 8 | 25 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 6 | 30 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Black or African American | 1 | 3 | 4 |
| White | 6 | 6 | 12 |
| Asian (Chinese) | 0 | 10 | 10 |
| Asian (Japanese) | 0 | 11 | 11 |
| Multiple | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Cohort A: Fixed Sequence of Meal Conditions | Cohort B: Comparison of Randomized Treatments | Total |
|---|---|---|---|
| United States | 8 | 31 | 39 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eli Lilly and Company