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Trial record 9 of 27 for:    Edivoxetine OR LY2216684

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
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: LY2216684
Drug: Digoxin
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2216684 + Digoxin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 30
Completed 24
Not Completed 6
Reason Not Completed
Adverse Event             3
Lost to Follow-up             1
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title LY2216684 + Digoxin
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
34.9  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
12
  40.0%
Male
18
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
19
  63.3%
Not Hispanic or Latino
11
  36.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  16.7%
White
23
  76.7%
More than one race
2
   6.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
1.Primary Outcome
Title Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax)
Hide Description Cmax of digoxin when administered alone and when co-administered with LY2216684.
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable Cmax values.
Arm/Group Title Digoxin LY2216684 + Digoxin
Hide Arm/Group Description:
0.5-milligrams (mg) (two 0.25-mg tablets) digoxin administered orally twice on Day 1 and 0.25-mg (single 0.25-mg tablet) digoxin administered orally once daily on Days 2 through 7.
0.25-mg (single 0.25-mg tablet) digoxin and 18-mg (two 9-mg tablets) LY2216684 administered orally once daily on Days 8 through 14.
Overall Number of Participants Analyzed 27 25
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanograms/milliliter (ng/mL)
1.433
(1.266 to 1.622)
1.424
(1.254 to 1.617)
2.Primary Outcome
Title Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax)
Hide Description Tmax of digoxin when administered alone and when co-administered with LY2216684.
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable Tmax values.
Arm/Group Title Digoxin LY2216684 + Digoxin
Hide Arm/Group Description:
0.5-milligrams (mg) (two 0.25-mg tablets) digoxin administered orally twice on Day 1 and 0.25-mg (single 0.25-mg tablet) digoxin administered orally once daily on Days 2 through 7.
0.25-mg (single 0.25-mg tablet) digoxin and 18-mg (two 9-mg tablets) LY2216684 administered orally once daily on Days 8 through 14.
Overall Number of Participants Analyzed 25 25
Median (Full Range)
Unit of Measure: hours
2.00
(0.50 to 3.00)
1.00
(0.50 to 4.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Digoxin, LY2216684 + Digoxin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0664
Comments [Not Specified]
Method Wilcoxon Signed Rank
Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt)
Hide Description AUCt at steady state of digoxin when administered alone and when co-administered with LY2216684.
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and evaluable AUCt values.
Arm/Group Title Digoxin LY2216684 + Digoxin
Hide Arm/Group Description:
0.5-milligrams (mg) (two 0.25-mg tablets) digoxin administered orally twice on Day 1 and 0.25-mg (single 0.25-mg tablet) digoxin administered orally once daily on Days 2 through 7.
0.25-mg (single 0.25-mg tablet) digoxin and 18-mg (two 9-mg tablets) LY2216684 administered orally once daily on Days 8 through 14.
Overall Number of Participants Analyzed 27 25
Geometric Mean (90% Confidence Interval)
Unit of Measure: hours*nanograms/milliliter (h*ng/mL)
14.6
(13.2 to 16.1)
14.3
(12.9 to 15.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digoxin 0.5mg Digoxin 0.25mg LY2216684 + Digoxin
Hide Arm/Group Description 0.5-milligrams (mg) (two 0.25-mg tablets) digoxin administered orally twice on Day 1. 0.25-mg (single 0.25-mg tablet) digoxin administered orally once daily on Days 2 through 7. 0.25-mg (single 0.25-mg tablet) digoxin and 18-mg (two 9-mg tablets) LY2216684 administered orally once daily on Days 8 through 14.
All-Cause Mortality
Digoxin 0.5mg Digoxin 0.25mg LY2216684 + Digoxin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Digoxin 0.5mg Digoxin 0.25mg LY2216684 + Digoxin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/28 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Digoxin 0.5mg Digoxin 0.25mg LY2216684 + Digoxin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/30 (10.00%)      4/28 (14.29%)      16/27 (59.26%)    
Eye disorders       
Xerophthalmia  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Gastrointestinal disorders       
Abdominal distension  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Constipation  1  0/30 (0.00%)  0 2/28 (7.14%)  2 1/27 (3.70%)  1
Diarrhoea  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Dry mouth  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  2
Nausea  1  0/30 (0.00%)  0 0/28 (0.00%)  0 5/27 (18.52%)  5
Vomiting  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
General disorders       
Application site irritation  1  1/30 (3.33%)  1 0/28 (0.00%)  0 0/27 (0.00%)  0
Chills  1  0/30 (0.00%)  0 0/28 (0.00%)  0 2/27 (7.41%)  3
Fatigue  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Feeling abnormal  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Pain  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations       
Pharyngitis  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Rhinitis  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Investigations       
Electrocardiogram pr shortened  1  1/30 (3.33%)  1 0/28 (0.00%)  0 0/27 (0.00%)  0
Electrocardiogram t wave abnormal  1  1/30 (3.33%)  1 0/28 (0.00%)  0 0/27 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Hyperkalaemia  1  0/30 (0.00%)  0 1/28 (3.57%)  1 0/27 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic naevus  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders       
Dizziness  1  0/30 (0.00%)  0 0/28 (0.00%)  0 2/27 (7.41%)  2
Dysaesthesia  1  0/30 (0.00%)  0 0/28 (0.00%)  0 2/27 (7.41%)  2
Headache  1  0/30 (0.00%)  0 0/28 (0.00%)  0 2/27 (7.41%)  2
Hypoaesthesia  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Paraesthesia  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  2
Psychiatric disorders       
Anxiety  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Renal and urinary disorders       
Pollakiuria  1  0/30 (0.00%)  0 1/28 (3.57%)  1 0/27 (0.00%)  0
Semenuria  1  0/18 (0.00%)  0 0/17 (0.00%)  0 2/16 (12.50%)  3
Urinary hesitation  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Reproductive system and breast disorders       
Genital disorder male  1  0/18 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Penile size reduced  1  0/18 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Testicular disorder  1  0/18 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Testicular pain  1  0/18 (0.00%)  0 0/17 (0.00%)  0 2/16 (12.50%)  2
Testicular swelling  1  0/18 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Testis discomfort  1  0/18 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders       
Dermatitis contact  1  0/30 (0.00%)  0 1/28 (3.57%)  1 2/27 (7.41%)  2
Papule  1  0/30 (0.00%)  0 1/28 (3.57%)  1 1/27 (3.70%)  1
Pruritus  1  0/30 (0.00%)  0 0/28 (0.00%)  0 2/27 (7.41%)  2
Rash  1  0/30 (0.00%)  0 0/28 (0.00%)  0 2/27 (7.41%)  2
Skin irritation  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Urticaria  1  0/30 (0.00%)  0 1/28 (3.57%)  1 0/27 (0.00%)  0
Vascular disorders       
Peripheral coldness  1  0/30 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01266590     History of Changes
Other Study ID Numbers: 12600
H9P-EW-LNCK ( Other Identifier: Eli Lilly and Company )
First Submitted: December 20, 2010
First Posted: December 24, 2010
Results First Submitted: February 17, 2018
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018