Trial Outcomes & Findings for Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers (NCT NCT02248259)
NCT ID: NCT02248259
Last Updated: 2024-04-25
Results Overview
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Results posted on
2024-04-25
Participant Flow
A randomised, open-label, 2-way crossover trial. The two treatment periods were separated by a washout period of at least 3 weeks.
Participant milestones
| Measure |
Extensive Metabolisers: Ref / Test
Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
|
Poor Metabolisers: Ref / Test
Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
|
Extensive Metabolisers: Test / Ref
Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
|
Poor Metabolisers: Test / Ref
Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
6
|
6
|
7
|
6
|
|
Treatment Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
STARTED
|
6
|
6
|
6
|
6
|
|
Treatment Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Extensive Metabolisers: Ref / Test
Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
|
Poor Metabolisers: Ref / Test
Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
|
Extensive Metabolisers: Test / Ref
Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
|
Poor Metabolisers: Test / Ref
Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers
Baseline characteristics by cohort
| Measure |
Extensive Metabolisers
n=13 Participants
Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
|
Poor Metabolisers
n=12 Participants
Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 Years
STANDARD_DEVIATION 8.36 • n=93 Participants
|
29.7 Years
STANDARD_DEVIATION 6.53 • n=4 Participants
|
31.0 Years
STANDARD_DEVIATION 7.49 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administrationPopulation: Pharmacokinetic set (PKS) which included all treated subjects who provided at least one evaluable primary or secondary endpoint in any of the study periods without important protocol violations with respect to the statistical evaluation of relative bioavailability.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084
Outcome measures
| Measure |
Extensive Metabolisers: Ref. Treatment
n=12 Participants
Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Extensive Metabolisers: Test Treatment
n=12 Participants
Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
Poor Metabolisers: Ref. Treatment
n=12 Participants
Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Poor Metabolisers: Test Treatment
n=12 Participants
Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
|---|---|---|---|---|
|
AUC0-infinity of BI 409306 and Its Metabolites
BI 409306
|
547 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 71.6
|
621 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 68.8
|
1560 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 45.5
|
1370 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 39.4
|
|
AUC0-infinity of BI 409306 and Its Metabolites
CD 13896
|
389 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 26.4
|
347 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 19.2
|
178 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 20.0
|
165 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 14.3
|
|
AUC0-infinity of BI 409306 and Its Metabolites
CD 14084
|
2120 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 10.9
|
2110 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 12.6
|
1810 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 15.7
|
1890 nanomole (nmol)*hour (h) /Liter (L)
Geometric Coefficient of Variation 14.2
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administrationPopulation: PKS
Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Outcome measures
| Measure |
Extensive Metabolisers: Ref. Treatment
n=12 Participants
Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Extensive Metabolisers: Test Treatment
n=12 Participants
Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
Poor Metabolisers: Ref. Treatment
n=12 Participants
Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Poor Metabolisers: Test Treatment
n=12 Participants
Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
|---|---|---|---|---|
|
Cmax of BI 409306 and Its Metabolites
BI 409306
|
264 nmol/L
Geometric Coefficient of Variation 67.8
|
246 nmol/L
Geometric Coefficient of Variation 60.2
|
564 nmol/L
Geometric Coefficient of Variation 50.5
|
432 nmol/L
Geometric Coefficient of Variation 35.4
|
|
Cmax of BI 409306 and Its Metabolites
CD 13896
|
139 nmol/L
Geometric Coefficient of Variation 41.6
|
110 nmol/L
Geometric Coefficient of Variation 35.5
|
44.9 nmol/L
Geometric Coefficient of Variation 33.3
|
42.8 nmol/L
Geometric Coefficient of Variation 16.2
|
|
Cmax of BI 409306 and Its Metabolites
CD 14084
|
714 nmol/L
Geometric Coefficient of Variation 21.5
|
620 nmol/L
Geometric Coefficient of Variation 19.1
|
470 nmol/L
Geometric Coefficient of Variation 35.8
|
505 nmol/L
Geometric Coefficient of Variation 20.3
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administrationPopulation: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz) of BI 409306 and its metabolites CD 13896 and CD 14084
Outcome measures
| Measure |
Extensive Metabolisers: Ref. Treatment
n=12 Participants
Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Extensive Metabolisers: Test Treatment
n=12 Participants
Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
Poor Metabolisers: Ref. Treatment
n=12 Participants
Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Poor Metabolisers: Test Treatment
n=12 Participants
Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
|---|---|---|---|---|
|
AUC0-tz of BI 409306 and Its Metabolites
BI 409306
|
546 nmol*h/L
Geometric Coefficient of Variation 71.6
|
620 nmol*h/L
Geometric Coefficient of Variation 68.8
|
1560 nmol*h/L
Geometric Coefficient of Variation 45.5
|
1370 nmol*h/L
Geometric Coefficient of Variation 39.4
|
|
AUC0-tz of BI 409306 and Its Metabolites
CD 13896
|
388 nmol*h/L
Geometric Coefficient of Variation 26.7
|
345 nmol*h/L
Geometric Coefficient of Variation 19.4
|
176 nmol*h/L
Geometric Coefficient of Variation 20.0
|
163 nmol*h/L
Geometric Coefficient of Variation 14.3
|
|
AUC0-tz of BI 409306 and Its Metabolites
CD 14084
|
2120 nmol*h/L
Geometric Coefficient of Variation 11.0
|
2110 nmol*h/L
Geometric Coefficient of Variation 12.6
|
1810 nmol*h/L
Geometric Coefficient of Variation 15.7
|
1890 nmol*h/L
Geometric Coefficient of Variation 14.2
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administrationPopulation: PKS
Time from dosing to the maximum concentration of the analyte in plasma (tmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Outcome measures
| Measure |
Extensive Metabolisers: Ref. Treatment
n=12 Participants
Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Extensive Metabolisers: Test Treatment
n=12 Participants
Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
Poor Metabolisers: Ref. Treatment
n=12 Participants
Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Poor Metabolisers: Test Treatment
n=12 Participants
Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
|---|---|---|---|---|
|
Tmax of BI 409306 and Its Metabolites
BI 409306
|
1.13 Hours
Interval 0.5 to 3.0
|
1.75 Hours
Interval 1.0 to 3.0
|
1.00 Hours
Interval 0.5 to 4.02
|
2.00 Hours
Interval 1.0 to 4.0
|
|
Tmax of BI 409306 and Its Metabolites
CD 13896
|
1.13 Hours
Interval 0.5 to 3.0
|
2.00 Hours
Interval 1.0 to 3.0
|
1.25 Hours
Interval 0.5 to 4.02
|
2.00 Hours
Interval 1.5 to 4.0
|
|
Tmax of BI 409306 and Its Metabolites
CD 14084
|
1.75 Hours
Interval 1.0 to 4.0
|
2.00 Hours
Interval 1.5 to 4.0
|
2.00 Hours
Interval 1.0 to 4.02
|
2.50 Hours
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administrationPopulation: PKS
Terminal half-life of the analyte in plasma (t1/2) of BI 409306 and its metabolites CD 13896 and CD 14084
Outcome measures
| Measure |
Extensive Metabolisers: Ref. Treatment
n=12 Participants
Participants who were extensive metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Extensive Metabolisers: Test Treatment
n=12 Participants
Participants who were extensive metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
Poor Metabolisers: Ref. Treatment
n=12 Participants
Participants who were poor metabolisers received 1 single tablet of 25 mg BI 409306 taken orally on day 1 (reference treatment)
|
Poor Metabolisers: Test Treatment
n=12 Participants
Participants who were poor metabolisers received 2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1 (test treatment)
|
|---|---|---|---|---|
|
t1/2 of BI 409306 and Its Metabolites
BI 409306
|
1.54 Hours
Geometric Coefficient of Variation 16.9
|
1.73 Hours
Geometric Coefficient of Variation 27.3
|
2.87 Hours
Geometric Coefficient of Variation 64.1
|
2.01 Hours
Geometric Coefficient of Variation 25.2
|
|
t1/2 of BI 409306 and Its Metabolites
CD 13896
|
2.51 Hours
Geometric Coefficient of Variation 21.4
|
2.16 Hours
Geometric Coefficient of Variation 21.1
|
2.26 Hours
Geometric Coefficient of Variation 20.7
|
2.17 Hours
Geometric Coefficient of Variation 16.8
|
|
t1/2 of BI 409306 and Its Metabolites
CD 14084
|
3.13 Hours
Geometric Coefficient of Variation 22.5
|
2.62 Hours
Geometric Coefficient of Variation 10.1
|
3.21 Hours
Geometric Coefficient of Variation 39.9
|
2.57 Hours
Geometric Coefficient of Variation 19.7
|
Adverse Events
Extensive Metabolizers: Itra
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Extensive Metabolizers: BI 409306
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Extensive Metabolizers: Itra+BI 409306
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Poor Metabolizers: Itra
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Poor Metabolizers: BI 409306
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Poor Metabolizers: Itra+BI 409306
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extensive Metabolizers: Itra
n=13 participants at risk
Participants who were extensive metabolisers receiving only 2 capsules of 100 mg itraconazole (Itra) taken orally twice daily.
|
Extensive Metabolizers: BI 409306
n=12 participants at risk
Participants who were extensive metabolisers receiving only 1 single tablet of 25 mg BI 409306 taken orally.
|
Extensive Metabolizers: Itra+BI 409306
n=12 participants at risk
Participants who were extensive metabolisers receiving 2 capsules of 100 mg itraconazole taken orally twice daily and 1 single tablet of 25 mg BI 409306 taken orally.
|
Poor Metabolizers: Itra
n=12 participants at risk
Participants who were poor metabolisers receiving only 2 capsules of 100 mg itraconazole taken orally twice daily.
|
Poor Metabolizers: BI 409306
n=12 participants at risk
Participants who were poor metabolisers receiving only 1 single tablet of 25 mg BI 409306 taken orally.
|
Poor Metabolizers: Itra+BI 409306
n=12 participants at risk
Participants who were poor metabolisers receiving 2 capsules of 100 mg itraconazole taken orally twice daily and 1 single tablet of 25 mg BI 409306 taken orally.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
General disorders
Sensation of foreign body
|
7.7%
1/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
16.7%
2/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/13 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
8.3%
1/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
0.00%
0/12 • From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Adverse events were analysed by the treatment being administered at the time of the adverse event.
|
Additional Information
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Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER