A Study of Evacetrapib and Digoxin in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Digoxin; Drug: Evacetrapib

• Registration Number: NCT01897493
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2018-02
• Results First Submitted: 2018-02-18
• Results First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digoxin	Digoxin	0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1
Evacetrapib + Digoxin	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
Evacetrapib + Digoxin	Evacetrapib	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin	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
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin	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
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin	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

Name	Time	Method
Renal Clearance (CLr) of Digoxin	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.

Trial Locations

Locations (1)

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