A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT01436201
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Digoxin — DRUG
    Administered orally
  • Dulaglutide — BIOLOGICAL
    Administered as subcutaneous injection

Study Details

The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body. Information about any side effects that may occur will also be collected. This study is for research purposes only and is not intended to treat any medical condition. This research study requires that a blood sample be obtained and stored for future research involving genetic analysis.

Key Dates

Start date
Sep 30, 2011
Status verified
Oct 2014
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Digoxin + Dulaglutide
    Digoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.

Primary Outcome Measure

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin [ Time Frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 ]

Locations (1)

FacilityCityStateZIPSite coordinators
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.Daytona BeachFlorida32117-

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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.· Daytona Beach, FL

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