HealthyPhase 1NCT02497391

A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

A Phase 1 study testing Evacetrapib in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

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

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Evacetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 1 siteSingapore
Study dates: Jul 2015to Nov 2015
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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

Trial locations and contacts

1 site in 1 country.

Singapore1 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.
Singapore, 117597

Other trials in Singapore

About this study

Official title: A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes

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.

Conditions: Healthy
Being tested: Evacetrapib

What participants receive

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

EvacetrapibDrug
Also called LY2484595
administered orally

Study groups in NCT02497391
Study group	Role	What they receive
Evacetrapib Reference (R)	Experimental	Single oral dose of 130 mg evacetrapib tablet given one time during one study period. Receives: Drug: Evacetrapib
Evacetrapib Test 1 (T1)	Experimental	Single oral dose of 130 mg evacetrapib tablet given one time during one study period. Receives: Drug: Evacetrapib
Evacetrapib Test 2 (T2)	Experimental	Single oral dose of 130 mg evacetrapib tablet given one time during one study period. Receives: Drug: Evacetrapib

What is being measured

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

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
Measured: 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
Measured: 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

Timeline

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

Jul 2015Nov 2015

First posted14 Jul 2015 (estimated)
Study startJul 2015
Primary completionNov 2015
Study completionNov 2015

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 HealthyStudies 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: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02497391
Sponsor's protocol ID: 14629
Other IDs: I1V-MC-EIBA
Status last verified: Nov 2018
First submitted: 10 Jul 2015
Last updated: 3 Dec 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?

See locations

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Study at a glance

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

Official title: A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes
ClinicalTrials.gov ID: NCT02497391
Acronym / sponsor ID: 14629
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 14 Jul 2015 (estimated)
Results: Posted 3 Dec 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: 3

Arm	Type	Receives
Evacetrapib Reference (R)	Experimental	Drug: EvacetrapibSingle oral dose of 130 mg evacetrapib tablet given one time during one study period.
Evacetrapib Test 1 (T1)	Experimental	Drug: EvacetrapibSingle oral dose of 130 mg evacetrapib tablet given one time during one study period.
Evacetrapib Test 2 (T2)	Experimental	Drug: EvacetrapibSingle oral dose of 130 mg evacetrapib tablet given one time during one study period.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

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
EvacetrapibAlso: LY2484595administered orally	Drug	Evacetrapib Reference (R), Evacetrapib Test 1 (T1), Evacetrapib Test 2 (T2)

Primary outcome

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 3 Dec 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
Sequence 1 (R/T1/T2)	16	16
Sequence 2 (T1/T2/R)	15	15
Sequence 3 (T2/R/T1)	16	16
Sequence 4 (T2/T1/R)	16	16
Sequence 5 (R/T2/T1)	16	16
Sequence 6 (T1/R/T2)	16	16

Primary outcome: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nangram/milliliter (ng/mL)

Measure	Evacetrapib Reference (R) n = 84	Evacetrapib Test 1 (T1) n = 81	Evacetrapib Test 2 (T2) n = 85
Value	983 (78)	1170 (56)	1120 (66)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib

Measure	Evacetrapib Reference (R) n = 84	Evacetrapib Test 1 (T1) n = 81	Evacetrapib Test 2 (T2) n = 85
Value	14700 (53)	16100 (45)	15500 (49)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable PK data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evacetrapib Reference (R)	0 of 84 (0%)	33 of 84 (39.3%)	Not reported
Evacetrapib Test 1 (T1)	0 of 81 (0%)	22 of 81 (27.2%)	Not reported
Evacetrapib Test 2 (T2)	0 of 85 (0%)	23 of 85 (27.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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?

A Phase 1 study testing Evacetrapib in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

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 3 inclusion and 1 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 Dec 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 Singapore. 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 Dec 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 (PK): Maximum Observed Concentration (Cmax) of Evacetrapib (time frame: 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). 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 NCT02497391.

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 Dec 2018.