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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836185
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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. This study will last approximately 28 days, not including screening.

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Drug: Evacetrapib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Evacetrapib (LY2484595) in Subjects With Hepatic Impairment
Study Start Date : April 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Evacetrapib (Healthy)
Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function
Drug: Evacetrapib
Other Name: LY2484595

Experimental: Evacetrapib (Hepatic, Mild)
Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment
Drug: Evacetrapib
Other Name: LY2484595

Experimental: Evacetrapib (Hepatic, Moderate)
Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment
Drug: Evacetrapib
Other Name: LY2484595

Experimental: Evacetrapib (Hepatic, Severe)
Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment
Drug: Evacetrapib
Other Name: LY2484595




Primary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836185


Locations
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United States, Florida
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, United States, 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, United States, 32806
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01836185    
Other Study ID Numbers: 14621
I1V-MC-EIAS ( Other Identifier: Eli Lilly and Company )
First Posted: April 19, 2013    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents