A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT01436201|
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Digoxin Biological: Dulaglutide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Dulaglutide (LY2189265) on the Pharmacokinetics of Digoxin in Healthy Subjects|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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 as subcutaneous injection
Other Name: LY2189265
- 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 ]
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin [ Time Frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|