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OpenTrials
Completed

NCT Number: NCT01897493

A Study of Evacetrapib and Digoxin in Healthy Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evacetrapib

Drug

Administered orally

Other names: LY2484595

Digoxin

Drug

Administered orally

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Evacetrapib on the Pharmacokinetics of Digoxin in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2013
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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