CClinicalTrials.gg
CompletedNCT01450098Updated Oct 3, 2018Results posted

A Study of LY2484595 in Healthy Subjects

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

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Are overtly healthy males or females, as determined by medical history and physical examination. For Cohort B, a first-generation Japanese subject is defined as one who is Japanese and was born in Japan and whose parents and all grandparents are Japanese and were born in Japan. A first-generation Chinese subject is defined as one who is Chinese and was born in China (mainland or Taiwan) and whose parents and all grandparents are Chinese and were born in China
  • Female subjects are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are at least age 45, have had cessation of menses for at least 1 year, and have not taken hormones or oral contraceptives (including estrogen or hormone replacement therapy) during the past 12 months
  • Have a body mass index (BMI) of 18.5 to 29.0 kilograms per meter squared (kg/m\^2), inclusive
  • Have clinical laboratory test results within normal reference range for the population or investigator site or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Have an acceptable blood pressure (BP) and heart rate at both supine and standing positions as determined by the investigator (systolic BP less than or equal to 140 millimeters of mercury [mmHg], and diastolic BP less than or equal to 90 mmHg). A single, repeat BP measurement may be done at the discretion of the investigator
  • Have venous access sufficient to allow blood sampling
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Have given written informed consent approved by Eli Lilly and Company (hereafter, Lilly) and the ethical review board (ERB) governing the site

Exclusion criteria

Exclusion Criteria:

  • Are currently enrolled in or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have known allergies to LY2484595 or related compounds
  • Are persons who have previously completed or withdrawn from this study
  • Have an abnormality in the 12-lead electrocardiogram (ECG) (including but not limited to a Bazett's corrected QT [QTcB] interval >450 milliseconds (msec) for men and >470 msec for women) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history within the last 2 years or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Show evidence of significant active neuropsychiatric disease
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Are women with a positive pregnancy test or women who are lactating
  • Intend to use and actually use over-the-counter or prescription medication or dietary supplements within 14 days prior to dosing (acetaminophen is permissible on an as-needed basis at less than 3 grams per day for less than 7 days)
  • Have donated blood of more than 500 milliliters (mL) within the last month
  • Have an average alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for 48 hours prior and during the inpatient confinement at the Clinical Research Unit (CRU) (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Use herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or starfruit within 7 days prior to study dosing
  • Smoke more than 10 cigarettes per day currently and are unwilling to abide by the CRU guidelines
  • Are unwilling to refrain from daily consumption of real licorice
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Cohort A: Fixed Sequence of Meal Conditions

    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)

  • Experimental
    Cohort B: Comparison of Randomized Treatments

    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)

Interventions

  • DrugLY2484595 Reference Formulation (RF)

    Administered orally

    Also known as: Evacetrapib

  • DrugLY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)

    Administered orally

    Also known as: Evacetrapib

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

07

Results

Posted Oct 3, 2018

Participant flow

Period 1
Participant flow — Period 1
MilestoneCohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized Treatments
Started831
Received at least 1 dose of study drug831
Completed831
Not completed00
Washout Period of at Least 14 Days
Participant flow — Washout Period of at Least 14 Days
MilestoneCohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized Treatments
Started831
Completed831
Not completed00
Period 2
Participant flow — Period 2
MilestoneCohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized Treatments
Started831
Received at least 1 dose of study drug831
Completed831
Not completed00
Washout of at Least 14 Days
Participant flow — Washout of at Least 14 Days
MilestoneCohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized Treatments
Started831
Completed831
Not completed00
Period 3
Participant flow — Period 3
MilestoneCohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized Treatments
Started831
Received at least 1 dose of study drug830
Completed828
Not completed03
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject02

Outcome measures

PrimaryPharmacokinetics: 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
Reported as:
Geometric mean · hours times nanograms per milliliter
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595
hours times nanograms per milliliterLY2484595 200 mg SDSD-PG FastedLY2484595 200 mg SDSD-PG Low FatLY2484595 200 mg SDSD-PG High Fat
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY248459512200 ± 2917800 ± 3117800 ± 29
PrimaryPharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595
Time frame:
Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose
Reported as:
Geometric mean · nanograms per milliliter
Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595
nanograms per milliliterLY2484595 200 mg SDSD-PG FastedLY2484595 200 mg SDSD-PG Low FatLY2484595 200 mg SDSD-PG High Fat
Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595828 ± 511510 ± 301280 ± 28
SecondaryNumber 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)
Reported as:
Number · participants
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
participantsLY2484595 100 mg RFLY2484595 100 mg SDSD-PGLY2484595 200 mg SDSD-PGLY2484595 300 mg SDSD-PG
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs0021

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Most frequent other events
EventLY2484595 100 mg RFLY2484595 100 mg SDSD-PGLY2484595 200 mg SDSD-PGLY2484595 300 mg SDSD-PG
FlatulenceGastrointestinal disorders0/300/301/80/31
HeadacheNervous system disorders0/300/301/80/31
EpistaxisRespiratory, thoracic and mediastinal disorders0/300/301/80/31
Aphthous stomatitisGastrointestinal disorders0/300/300/81/31
GastroenteritisInfections and infestations0/300/300/81/31
Transaminases increasedInvestigations0/300/300/81/31
CoughRespiratory, thoracic and mediastinal disorders0/300/300/81/31
RashSkin and subcutaneous tissue disorders0/300/300/81/31

Baseline characteristics

All participants who received at least 1 dose of study drug

Age, Continuous
Age, Continuous(years)Cohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized TreatmentsTotal
Mean32.0 ± 6.237.3 ± 11.436.2 ± 10.73
Sex: Female, Male
Sex: Female, Male(Participants)Cohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized TreatmentsTotal
Female066
Male82533
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized TreatmentsTotal
Hispanic or Latino213
Not Hispanic or Latino63036
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized TreatmentsTotal
American Indian or Alaska Native101
Black or African American134
White6612
Asian (Chinese)01010
Asian (Japanese)01111
Multiple011
Region of Enrollment
Region of Enrollment(Participants)Cohort A: Fixed Sequence of Meal ConditionsCohort B: Comparison of Randomized TreatmentsTotal
United States83139
08

Study locations

1 site
  • 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.
    Glendale, California 91206, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01450098
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 12, 2011
Start date
Oct 2011
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
Oct 3, 2018
Last update
Oct 3, 2018

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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