Healthy VolunteersPhase 1NCT01958489

A Study of Evacetrapib in Japanese and Non-Japanese Participants

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

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 main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time. This study has two periods in fixed order. 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?: Evacetrapib and Pravastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2013to Jan 2014
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

Overtly healthy participants, as determined by medical history and physical examination
Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
Japanese participants must be first generation Japanese

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 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.
Leeds, West Yorkshire, LS2 9LH

Other trials in United Kingdom

About this study

Official title: Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

Conditions: Healthy Volunteers
Being tested: Evacetrapib, Pravastatin

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
PravastatinDrug
Administered orally

Study groups in NCT01958489
Study group	Role	What they receive
Pravastatin	Experimental	Single 40 milligram (mg) oral dose of pravastatin administered on Day 1. Receives: Drug: Pravastatin
Evacetrapib + Pravastatin	Experimental	Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11. Receives: Drug: Evacetrapib; Drug: Pravastatin

What is being measured

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
Measured: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin
Measured: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin
Measured: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose

Timeline

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

Oct 2013Jan 2014

First posted9 Oct 2013 (estimated)
Study startOct 2013
Primary completionJan 2014
Study completionJan 2014

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01958489
Sponsor's protocol ID: 14625
Other IDs: I1V-MC-EIAW
Status last verified: Feb 2018
First submitted: 7 Oct 2013
Last updated: 9 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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects
ClinicalTrials.gov ID: NCT01958489
Acronym / sponsor ID: 14625
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 9 Oct 2013 (estimated)
Results: Posted 9 Oct 2018

Clinical summary

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

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pravastatin	Experimental	Drug: PravastatinSingle 40 milligram (mg) oral dose of pravastatin administered on Day 1.
Evacetrapib + Pravastatin	Experimental	Drug: Evacetrapib, Drug: PravastatinOral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.

Who may qualify

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

Key inclusion criteria (3 listed)

Overtly healthy participants, as determined by medical history and physical examination
Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
Japanese participants must be first generation Japanese

Key exclusion criteria (0 listed)

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 + Pravastatin
PravastatinAdministered orally	Drug	Evacetrapib + Pravastatin, Pravastatin

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin
Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin
Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose

Results and safety

Results posted to the registry on 9 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
Pravastatin	24	24
Evacetrapib + Pravastatin	0	0

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin

Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	Pravastatin (Period 1) n = 23	Evacetrapib + Pravastatin (Period 2) n = 23
Value	142 (31)	128 (43)

Population analysed: All participants who had evaluable Cmax results at the specific time points.

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

Measure	Pravastatin (Period 1) n = 23	Evacetrapib + Pravastatin (Period 2) n = 23
Value	257 (27)	229 (37)

Population analysed: All participants who had evaluable AUC(0-∞) at the specific time points.

Primary outcome: PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin

Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose. Median (Full Range). Unit: hours

Measure	Pravastatin (Period 1) n = 23	Evacetrapib + Pravastatin (Period 2) n = 23
Value	1.00 (0.50 to 2.00)	0.75 (0.50 to 1.50)

Population analysed: All enrolled participants with evaluable tmax results at the specific time points.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
40 mg Pravastatin Japanese	0 of 10 (0%)	2 of 10 (20%)	Not reported
130 mg Evacetrapib Japanese	0 of 10 (0%)	6 of 10 (60%)	Not reported
40 mg Pravastatin + 130 mg Evacetrapib Japanese	0 of 10 (0%)	4 of 10 (40%)	Not reported
40 mg Pravastatin Non-Japanese	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
130 mg Evacetrapib Non-Japanese	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
40 mg Pravastatin + 130-mg Evacetrapib Non-Japanese	0 of 13 (0%)	6 of 13 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 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?

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

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 0 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 9 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 Kingdom. 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 9 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 (PK): Maximum Concentration (Cmax) of Pravastatin (time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose). The study lists 3 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 NCT01958489.

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 9 Oct 2018.