A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants
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.
Diabetes Mellitus, Type 2
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Dulaglutide (LY2189265) on the Pharmacokinetics of Digoxin in Healthy Subjects|
- 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 ] [ Designated as safety issue: No ]
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin [ Time Frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 ] [ Designated as safety issue: No ]
- Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin [ Time Frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
Administered orallyBiological: Dulaglutide
Administered as subcutaneous injection
Other Name: LY2189265
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436201
|United States, Florida|
|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, Florida, United States, 32117|
|Study Director:||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)||Eli Lilly and Company|