Hepatic InsufficiencyPhase 1NCT01836185

A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment

A Phase 1 study testing Evacetrapib in people with Hepatic Insufficiency, run by Eli Lilly and Company at 2 sites 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 is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency
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: 32 participants
Where: 2 sitesUnited States
Study dates: Apr 2013to Oct 2013
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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants have given written informed consent approved by the ethical review board (ERB) governing the site
Female participants should be of non-childbearing potential
Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Who cannot join

Has had esophagus variceal bleeding within 3 months of check-in
Have the need to take medications that may interfere with how the liver removes the drug
Have evidence of cancer in the liver
Consumes excessively large amounts of drinks with caffeine or alcohol

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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.
Miami, Florida, 33169
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.
Orlando, Florida, 32806

Other trials in United States

About this study

Official title: Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment

Conditions: Hepatic Insufficiency
Being tested: Evacetrapib
Medical subject headings: Hepatic Insufficiency

What participants receive

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

EvacetrapibDrug
Also called LY2484595

Study groups in NCT01836185
Study group	Role	What they receive
Evacetrapib (Healthy)	Experimental	Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function Receives: Drug: Evacetrapib
Evacetrapib (Hepatic, Mild)	Experimental	Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment Receives: Drug: Evacetrapib
Evacetrapib (Hepatic, Moderate)	Experimental	Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment Receives: Drug: Evacetrapib
Evacetrapib (Hepatic, Severe)	Experimental	Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment Receives: Drug: Evacetrapib

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib
tlast is defined as the last time point with a measurable concentration of Evacetrapib.
Measured: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
PK: Maximum Observed Concentration (Cmax) of Evacetrapib
Measured: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Measured: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose

Timeline

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

Apr 2013Oct 2013

First posted19 Apr 2013 (estimated)
Study startApr 2013
Primary completionOct 2013
Study completionOct 2013

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 Hepatic InsufficiencyStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01836185
Sponsor's protocol ID: 14621
Other IDs: I1V-MC-EIAS
Status last verified: Oct 2018
First submitted: 17 Apr 2013
Last updated: 12 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?

See locations

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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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All Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment
ClinicalTrials.gov ID: NCT01836185
Acronym / sponsor ID: 14621
Conditions: Hepatic Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 19 Apr 2013 (estimated)
Results: Posted 12 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Evacetrapib (Healthy)	Experimental	Drug: EvacetrapibGroup 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function
Evacetrapib (Hepatic, Mild)	Experimental	Drug: EvacetrapibGroup 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment
Evacetrapib (Hepatic, Moderate)	Experimental	Drug: EvacetrapibGroup 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment
Evacetrapib (Hepatic, Severe)	Experimental	Drug: EvacetrapibGroup 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants have given written informed consent approved by the ethical review board (ERB) governing the site
Female participants should be of non-childbearing potential
Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Key exclusion criteria (4 listed)

Has had esophagus variceal bleeding within 3 months of check-in
Have the need to take medications that may interfere with how the liver removes the drug
Have evidence of cancer in the liver
Consumes excessively large amounts of drinks with caffeine or alcohol

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: LY2484595	Drug	Evacetrapib (Healthy), Evacetrapib (Hepatic, Mild), Evacetrapib (Hepatic, Moderate), Evacetrapib (Hepatic, Severe)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib
Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
tlast is defined as the last time point with a measurable concentration of Evacetrapib.
PK: Maximum Observed Concentration (Cmax) of Evacetrapib
Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose

Results and safety

Results posted to the registry on 12 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
Evacetrapib (Healthy)	10	10
Evacetrapib (Hepatic, Mild)	8	8
Evacetrapib (Hepatic, Moderate)	8	8
Evacetrapib (Hepatic, Severe)	6	6

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib

Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour per milliliter (ng*h/mL)

Measure	Evacetrapib (Healthy) n = 10	Evacetrapib (Hepatic, Mild) n = 8	Evacetrapib (Hepatic, Moderate) n = 8	Evacetrapib (Hepatic, Severe) n = 6
Value	10700 (50)	10500 (84)	13200 (49)	15800 (62)

Population analysed: Participants who received at least 1 dose of study drug and had evaluable PK (AUC0-tlast) data.

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

Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Evacetrapib (Healthy) n = 10	Evacetrapib (Hepatic, Mild) n = 8	Evacetrapib (Hepatic, Moderate) n = 8	Evacetrapib (Hepatic, Severe) n = 6
Value	605 (98)	609 (144)	591 (58)	478 (51)

Population analysed: Participants who received at least 1 dose of study drug and had evaluable PK (Cmax) data.

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

Time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose. Mean (Full Range). Unit: h

Measure	Evacetrapib (Healthy) n = 10	Evacetrapib (Hepatic, Mild) n = 8	Evacetrapib (Hepatic, Moderate) n = 8	Evacetrapib (Hepatic, Severe) n = 6
Value	3 (2 to 6)	3 (1 to 4)	3 (2 to 4)	3 (2 to 6)

Population analysed: Participants who received at least one dose of study drug and had evaluable PK data.

Adverse events

Time frame: Randomization to study completion (Up To 41 Days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evacetrapib (Healthy)	0 of 10 (0%)	2 of 10 (20%)	Not reported
Evacetrapib (Hepatic, Mild)	0 of 8 (0%)	4 of 8 (50%)	Not reported
Evacetrapib (Hepatic, Moderate)	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Evacetrapib (Hepatic, Severe)	0 of 6 (0%)	3 of 6 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatic Insufficiency

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Not yet recruiting
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Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
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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

2 sites 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 Hepatic Insufficiency, run by Eli Lilly and Company at 2 sites in United States.

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 5 inclusion and 4 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 12 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 2 sites 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 12 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): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib (time frame: Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose). 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 NCT01836185.

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 12 Oct 2018.