Trial Outcomes & Findings for 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 (NCT NCT01301742)
NCT ID: NCT01301742
Last Updated: 2014-06-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
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
Results posted on
2014-06-18
Participant Flow
Participant milestones
| Measure |
Empa First, Then Empa and Gemfibrozil
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.
|
Empa and Gemfibrozil First, Then Empa
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.
|
|---|---|---|
|
First Intervention
STARTED
|
9
|
9
|
|
First Intervention
COMPLETED
|
9
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of at Least 7 Days
STARTED
|
9
|
9
|
|
Washout Period of at Least 7 Days
COMPLETED
|
9
|
9
|
|
Washout Period of at Least 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
9
|
9
|
|
Second Intervention
COMPLETED
|
9
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=18 Participants
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.
|
|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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.
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).
Outcome measures
| Measure |
Empa Alone
n=18 Participants
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
|
Empa and Gemfibrozil
n=18 Participants
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.
|
|---|---|---|
|
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
|
4708.33 nmol*h/L
Geometric Coefficient of Variation 7.5
|
7462.74 nmol*h/L
Geometric Coefficient of Variation 7.5
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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.
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).
Outcome measures
| Measure |
Empa Alone
n=18 Participants
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
|
Empa and Gemfibrozil
n=18 Participants
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.
|
|---|---|---|
|
Total Empa: Maximum Measured Concentration (Cmax)
|
602.24 nmol/L
Geometric Coefficient of Variation 13.8
|
692.59 nmol/L
Geometric Coefficient of Variation 13.8
|
SECONDARY outcome
Timeframe: 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 dosePopulation: 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.
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).
Outcome measures
| Measure |
Empa Alone
n=18 Participants
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
|
Empa and Gemfibrozil
n=18 Participants
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.
|
|---|---|---|
|
Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
|
4643.81 nmol*h/L
Geometric Coefficient of Variation 7.7
|
7350.84 nmol*h/L
Geometric Coefficient of Variation 7.7
|
Adverse Events
Empa Alone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Empa and Gemfibrozil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Gemfibrozil Alone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Empa Alone
n=18 participants at risk
Empagliflozin (Empa) 25mg given as a single dose on Day 1.
|
Empa and Gemfibrozil
n=18 participants at risk
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.
|
Gemfibrozil Alone
n=18 participants at risk
Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
5.6%
1/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
|
Vascular disorders
Haematoma
|
11.1%
2/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
0.00%
0/18 • First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place