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A Study of Evacetrapib and Digoxin in Healthy Participants

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Evacetrapib (Drug); Digoxin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

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.

Clinical Details

Official title: Effect of Evacetrapib on the Pharmacokinetics of Digoxin in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Digoxin

Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (tmax) of Digoxin

Secondary outcome: Renal Clearance (CLr) of Digoxin

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Overtly healthy males and females (of non child-bearing 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

Locations and Contacts

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 75247, United States
Additional Information

Starting date: July 2013
Last updated: September 19, 2013

Page last updated: August 23, 2015

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