Healthy VolunteersPhase 1NCT01450098

A Study of LY2484595 in Healthy Subjects

A Phase 1 study testing LY2484595 Reference Formulation (RF) and LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG) in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY2484595 Reference Formulation (RF) and LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Dec 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 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

Other trials in United States

About this study

Official title: Single Dose LY2484595 Tablet Formulations to Determine the Impact of Dose Level, Food, and Ethnicity on the Pharmacokinetics in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: LY2484595 Reference Formulation (RF), LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2484595 Reference Formulation (RF)Drug
Also called Evacetrapib
Administered orally
LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)Drug
Also called Evacetrapib
Administered orally

Study groups in NCT01450098
Study group	Role	What they receive
Cohort A: Fixed Sequence of Meal Conditions	Experimental	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. Receives: Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Cohort B: Comparison of Randomized Treatments	Experimental	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. Receives: Drug: LY2484595 Reference Formulation (RF); Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose
Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595
Measured: 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.
Measured: Baseline through completion of study (approximately 2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Dec 2011

First posted12 Oct 2011 (estimated)
Study startOct 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01450098
Sponsor's protocol ID: 13697
Other IDs: I1V-MC-EIAJ
Status last verified: Feb 2018
First submitted: 7 Oct 2011
Last updated: 3 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Dose LY2484595 Tablet Formulations to Determine the Impact of Dose Level, Food, and Ethnicity on the Pharmacokinetics in Healthy Subjects
ClinicalTrials.gov ID: NCT01450098
Acronym / sponsor ID: 13697
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 12 Oct 2011 (estimated)
Results: Posted 3 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A: Fixed Sequence of Meal Conditions	Experimental	Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)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.
Cohort B: Comparison of Randomized Treatments	Experimental	Drug: LY2484595 Reference Formulation (RF), 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2484595 Reference Formulation (RF)Also: EvacetrapibAdministered orally	Drug	Cohort B: Comparison of Randomized Treatments
LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)Also: EvacetrapibAdministered orally	Drug	Cohort A: Fixed Sequence of Meal Conditions, Cohort B: Comparison of Randomized Treatments

Primary outcome

Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose
Area under the concentration-time curve from time zero to infinity is presented.
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

1 secondary outcome

Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline through completion of study (approximately 2 months)

Results and safety

Results posted to the registry on 3 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Fixed Sequence of Meal Conditions	8	8
Cohort B: Comparison of Randomized Treatments	31	31

Primary outcome: Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595

Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours times nanograms per milliliter

Measure	LY2484595 200 mg SDSD-PG Fasted n = 7	LY2484595 200 mg SDSD-PG Low Fat n = 8	LY2484595 200 mg SDSD-PG High Fat n = 7
Value	12200 (29)	17800 (31)	17800 (29)

Population analysed: All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 plasma concentration data

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter

Measure	LY2484595 200 mg SDSD-PG Fasted n = 8	LY2484595 200 mg SDSD-PG Low Fat n = 8	LY2484595 200 mg SDSD-PG High Fat n = 8
Value	828 (51)	1510 (30)	1280 (28)

Population analysed: All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 maximum observed plasma concentration data

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2484595 100 mg RF	0 of 30 (0%)	0 of 30 (0%)	Not reported
LY2484595 100 mg SDSD-PG	0 of 30 (0%)	0 of 30 (0%)	Not reported
LY2484595 200 mg SDSD-PG	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
LY2484595 300 mg SDSD-PG	0 of 31 (0%)	4 of 31 (12.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595 (time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01450098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.