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A Study of Evacetrapib and Digoxin in Healthy Participants

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: NCT01897493
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Evacetrapib Drug: Digoxin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Evacetrapib on the Pharmacokinetics of Digoxin in Healthy Subjects
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Digoxin
0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1
 Drug: Digoxin
Administered orally
Experimental: Evacetrapib + Digoxin
130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
 Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Drug: Digoxin
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin [ Time Frame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin ]
  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin [ Time Frame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin ]
  3. PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin [ Time Frame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin ]

Secondary Outcome Measures :
  1. Renal Clearance (CLr) of Digoxin [ Time Frame: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin ]
    CLr was defined as the volume of serum cleared of digoxin per unit of time after a single dose of digoxin.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overtly healthy males and females (of non-childbearing potential)
  • Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
  • Normal renal function

Exclusion Criteria:

  • Participants who currently smoke or use tobacco or nicotine products
Contacts and Locations
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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): NCT01897493


Locations
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United States, Texas
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.
Dallas, Texas, United States, 75247
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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01897493    
Other Study ID Numbers: 14619
I1V-MC-EIAQ ( Other Identifier: Eli Lilly and Company )
First Posted: July 12, 2013    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Digoxin
Evacetrapib
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents