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Trial record 42 of 729 for:    Area Under Curve AND Bioavailability

Drug Interaction Study of Digoxin and BI 10773

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ClinicalTrials.gov Identifier: NCT01306175
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Digoxin plus BI 10773
Drug: Digoxin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Total
Hide Arm/Group Description

This was a randomised, two-period cross-over trial, the two treatments administered were

  • A single dose of 0.5mg digoxin on day 1
  • empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5

Between treatment periods there was a washout period of at least 14 days.

Period Title: First Intervention
Started 20
Completed 20
Not Completed 0
Period Title: Washout Period of at Least 14 Days
Started 20
Completed 20
Not Completed 0
Period Title: Second Intervention
Started 20
Completed 20
Not Completed 0
Arm/Group Title Study Total
Hide Arm/Group Description

This was a randomised, two-period, cross-over trial, the two treatments administered were

  • A single dose of digoxin 0.5 mg on day 1
  • Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5

Between treatment periods there was a washout period of at least 14 days.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
34.3  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
1.Primary Outcome
Title Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.
Time Frame 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.
Arm/Group Title Digoxin Alone Digoxin and Empa
Hide Arm/Group Description:
A single dose of digoxin 0.5 mg on day 1.
Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
Overall Number of Participants Analyzed 20 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng-h/mL
37.8
(23.2%)
39.9
(26.0%)
2.Primary Outcome
Title Digoxin: Maximum Measured Concentration (Cmax)
Hide Description Maximum measured concentration of digoxin, per period.
Time Frame 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.
Arm/Group Title Digoxin Alone Digoxin and Empa
Hide Arm/Group Description:
A single dose of digoxin 0.5 mg on day 1.
Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
Overall Number of Participants Analyzed 20 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.97
(43.3%)
2.25
(33.8%)
3.Secondary Outcome
Title Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)
Hide Description Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.
Time Frame 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.
Arm/Group Title Digoxin Alone Digoxin and Empa
Hide Arm/Group Description:
A single dose of digoxin 0.5 mg on day 1.
Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
Overall Number of Participants Analyzed 20 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
24.8
(24.8%)
28.4
(24.3%)
Time Frame First administration of trial medication until 7 days after last administration of trial medication for Digoxin and BI 10773 + Digoxin, 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digoxin Alone Digoxin and Empa
Hide Arm/Group Description A single dose of digoxin 0.5 mg on day 1. Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
All-Cause Mortality
Digoxin Alone Digoxin and Empa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Digoxin Alone Digoxin and Empa
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Digoxin Alone Digoxin and Empa
Affected / at Risk (%) Affected / at Risk (%)
Total   2/20 (10.00%)   0/20 (0.00%) 
General disorders     
Fatigue  1  2/20 (10.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01306175     History of Changes
Other Study ID Numbers: 1245.40
2010-023170-40 ( EudraCT Number: EudraCT )
First Submitted: February 28, 2011
First Posted: March 1, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014