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Trial record 31 of 3084 for:    Area Under Curve AND Healthy

Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01301742
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : June 18, 2014
Last Update Posted : June 18, 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: BI 10773
Drug: Gemfibrozil
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Empa First, Then Empa and Gemfibrozil Empa and Gemfibrozil First, Then Empa
Hide Arm/Group Description Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions. Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1.
Period Title: First Intervention
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Washout Period of at Least 7 Days
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Second Intervention
Started 9 9
Completed 9 9
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description

The two treatments given in a randomised order were:

  • Empagliflozin 25mg (Empa) was given as a single dose on Day 1
  • Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.

Between treatments there was a washout period of at least 7 days.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
35.1  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
7
  38.9%
Male
11
  61.1%
1.Primary Outcome
Title Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description

Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.

The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

Time Frame 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.
Arm/Group Title Empa Alone Empa and Gemfibrozil
Hide Arm/Group Description:
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
4708.33
(7.5%)
7462.74
(7.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Alone, Empa and Gemfibrozil
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa and gemfibrozil divided by empa alone
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 158.50
Confidence Interval (2-Sided) 90%
151.77 to 165.53
Parameter Dispersion
Type: Standard Deviation
Value: 7.5
Estimation Comments Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)
2.Primary Outcome
Title Total Empa: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.

The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

Time Frame 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.
Arm/Group Title Empa Alone Empa and Gemfibrozil
Hide Arm/Group Description:
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
602.24
(13.8%)
692.59
(13.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Alone, Empa and Gemfibrozil
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa and gemfibrozil divided by empa alone
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 115.00
Confidence Interval (2-Sided) 90%
106.15 to 124.59
Parameter Dispersion
Type: Standard Deviation
Value: 13.8
Estimation Comments Standard deviation is actually the intra-individual gCV
3.Secondary Outcome
Title Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Hide Description

Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.

The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).

Time Frame 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.
Arm/Group Title Empa Alone Empa and Gemfibrozil
Hide Arm/Group Description:
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
4643.81
(7.7%)
7350.84
(7.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Alone, Empa and Gemfibrozil
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa and gemfibrozil divided by empa alone
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 158.29
Confidence Interval (2-Sided) 90%
151.41 to 165.49
Parameter Dispersion
Type: Standard Deviation
Value: 7.7
Estimation Comments Standard deviation is actually the intra-individual gCV
Time Frame First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Empa Alone Empa and Gemfibrozil Gemfibrozil Alone
Hide Arm/Group Description Empagliflozin (Empa) 25mg given as a single dose on Day 1. Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
All-Cause Mortality
Empa Alone Empa and Gemfibrozil Gemfibrozil Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empa Alone Empa and Gemfibrozil Gemfibrozil Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Empa Alone Empa and Gemfibrozil Gemfibrozil Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/18 (44.44%)   3/18 (16.67%)   6/18 (33.33%) 
Gastrointestinal disorders       
Diarrhoea  1  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Dyspepsia  1  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Infections and infestations       
Oral herpes  1  1/18 (5.56%)  0/18 (0.00%)  0/18 (0.00%) 
Rhinitis  1  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders       
Muscle disorder  1  1/18 (5.56%)  0/18 (0.00%)  0/18 (0.00%) 
Muscle tightness  1  1/18 (5.56%)  0/18 (0.00%)  0/18 (0.00%) 
Pain in extremity  1  0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Nervous system disorders       
Dizziness  1  1/18 (5.56%)  1/18 (5.56%)  0/18 (0.00%) 
Headache  1  4/18 (22.22%)  1/18 (5.56%)  1/18 (5.56%) 
Renal and urinary disorders       
Nocturia  1  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Pollakiuria  1  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders       
Dysphonia  1  0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders       
Erythema  1  0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Vascular disorders       
Haematoma  1  2/18 (11.11%)  0/18 (0.00%)  0/18 (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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01301742     History of Changes
Other Study ID Numbers: 1245.58
2010-023152-85 ( EudraCT Number: EudraCT )
First Submitted: February 22, 2011
First Posted: February 23, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014