A Study of LY2216684 and Digoxin in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01266590|
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: LY2216684 Drug: Digoxin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of LY2216684 on the Pharmacokinetics of Digoxin in Healthy Subjects|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: LY2216684 + digoxin
Two oral 0.5-milligrams (mg) (two 0.25-mg tablets) doses of digoxin separated by 12 hours on Day 1, followed by once daily 0.25-mg (single 0.25-mg tablet) dose of digoxin on Days 2-14. Daily oral 18-mg (two 9-mg tablets) doses of LY2216684 on Days 8-14.
- Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14 ]Cmax of digoxin when administered alone and when co-administered with LY2216684.
- Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14 ]Tmax of digoxin when administered alone and when co-administered with LY2216684.
- Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14 ]AUCt at steady state of digoxin when administered alone and when co-administered with LY2216684.
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): NCT01266590
|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|
|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|