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A Study of Evacetrapib and Digoxin in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Evacetrapib
Drug: Digoxin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01897493
14619
I1V-MC-EIAQ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Digoxin
Active Comparator group
Description:
0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1
Treatment:
Drug: Digoxin
Evacetrapib + Digoxin
Experimental group
Description:
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
Treatment:
Drug: Digoxin
Drug: Evacetrapib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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