Trial Outcomes & Findings for To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days (NCT NCT02733627)
NCT ID: NCT02733627
Last Updated: 2021-06-07
Results Overview
Number of subjects with investigator defined drug-related adverse events (AEs) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Results posted on
2021-06-07
Participant Flow
This was a double-blind, randomised, placebo-controlled within parallel dose groups, multiple dose trial.Only male subjects \& postmenopausal or surgically sterilised female subjects were included into trial because at time of trial start-up no data on reproductive toxicology were available.
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
Participant milestones
| Measure |
BI 1467335 10 mg (Low Dose)
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
BI 1467335 10 mg (Low Dose)
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawn due laboratory reason concerning neutrophils in agreement with the sponsor
|
0
|
0
|
1
|
0
|
Baseline Characteristics
TS
Baseline characteristics by cohort
| Measure |
BI 1467335 10 mg (Low Dose)
n=9 Participants
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=9 Participants
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=9 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
n=9 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.7 Years
STANDARD_DEVIATION 7.9 • n=5 Participants • TS
|
33.8 Years
STANDARD_DEVIATION 8.0 • n=7 Participants • TS
|
35.2 Years
STANDARD_DEVIATION 8.4 • n=5 Participants • TS
|
38.7 Years
STANDARD_DEVIATION 9.8 • n=4 Participants • TS
|
36.8 Years
STANDARD_DEVIATION 8.5 • n=21 Participants • TS
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • TS
|
1 Participants
n=7 Participants • TS
|
1 Participants
n=5 Participants • TS
|
3 Participants
n=4 Participants • TS
|
8 Participants
n=21 Participants • TS
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • TS
|
8 Participants
n=7 Participants • TS
|
8 Participants
n=5 Participants • TS
|
6 Participants
n=4 Participants • TS
|
28 Participants
n=21 Participants • TS
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants • TS
|
9 Participants
n=7 Participants • TS
|
9 Participants
n=5 Participants • TS
|
9 Participants
n=4 Participants • TS
|
36 Participants
n=21 Participants • TS
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
1 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
1 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants • TS
|
9 Participants
n=7 Participants • TS
|
7 Participants
n=5 Participants • TS
|
9 Participants
n=4 Participants • TS
|
34 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
1 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
1 Participants
n=21 Participants • TS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
PRIMARY outcome
Timeframe: From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.Population: Treated set (TS): All participants who received at least 1 dose of trial medication.
Number of subjects with investigator defined drug-related adverse events (AEs) is reported.
Outcome measures
| Measure |
BI 1467335 10 mg (Low Dose)
n=9 Participants
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=9 Participants
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=9 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
n=9 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
Number of Subjects With Investigator Defined Drug-related Adverse Events
|
3 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0:00 hour (h) (within 30 minutes prior to dosing) and 0:15 h, 0:30 h, 0:45 h, 1:00 h, 1:30 h, 2:00 h, 3:00 h, 4:00 h, 6:00 h, 8:00 h, 10:00 h, 12:00 h and 24:00 h after drug administration on Day 1.Population: Pharmacokinetic parameter analysis set (PKS): All participants of the TS who provided at least 1 pharmacokinetic (PK) parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability. Participants of the "Placebo" arm were not included in the analysis.
Cmax is the maximum measured concentration of BI 1467335 in plasma after administration of the first dose.
Outcome measures
| Measure |
BI 1467335 10 mg (Low Dose)
n=9 Participants
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=9 Participants
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=9 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
Cmax
|
1.79 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 45.9
|
9.74 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 30.6
|
25.0 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 59.5
|
—
|
SECONDARY outcome
Timeframe: 0:00 hour (h) (within 30 minutes prior to dosing) and 0:15 h, 0:30 h, 0:45 h, 1:00 h, 1:30 h, 2:00 h, 3:00 h, 4:00 h, 6:00 h, 8:00 h, 10:00 h, 12:00 h and 24:00 h after drug administration on Day 1.Population: Pharmacokinetic parameter analysis set (PKS): All participants of the TS who provided at least 1 pharmacokinetic (PK) parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability.
AUC0-24 is the area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose.
Outcome measures
| Measure |
BI 1467335 10 mg (Low Dose)
n=8 Participants
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=8 Participants
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=9 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
AUC0-24
|
2.34 nanomol*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 61.2
|
17.0 nanomol*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 40.6
|
41.6 nanomol*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 39.7
|
—
|
SECONDARY outcome
Timeframe: 648:00 hours (h) (within 30 minutes prior to dosing) and 648:15 h, 648:30 h, 648:45 h, 649:00h, 649:30 h, 650:00 h, 651:00 h, 652:00 h, 654:00 h, 656:00 h, 658:00 h, 660:00 h, 672:00 h after first drug administration on Day 1.Population: Pharmacokinetic parameter analysis set (PKS): All participants of the TS who provided at least 1 pharmacokinetic (PK) parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability.
Cmax,28 is the maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose.
Outcome measures
| Measure |
BI 1467335 10 mg (Low Dose)
n=9 Participants
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=8 Participants
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=7 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
Cmax,28
|
72.1 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 71.0
|
189 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 15.3
|
255 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 24.6
|
—
|
SECONDARY outcome
Timeframe: 648:00 hours (h) (within 30 minutes prior to dosing) and 648:15 h, 648:30 h, 648:45 h, 649:00 h, 649:30 h, 650:00 h, 651:00 h, 652:00 h, 654:00 h, 656:00 h, 658:00 h, 660:00 h and 672:00 h after first drug administration on Day 1.Population: Pharmacokinetic parameter analysis set (PKS): All participants of the TS who provided at least 1 pharmacokinetic (PK) parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability. Participants of the "Placebo" arm were excluded from the analysis.
AUC0-24,28 is the area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the 28th dose.
Outcome measures
| Measure |
BI 1467335 10 mg (Low Dose)
n=9 Participants
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=8 Participants
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=7 Participants
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
AUC0-24,28
|
373 nanomol*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 143
|
1720 nanomol*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 12.8
|
2940 nanomol*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 29.5
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 1467335 10 mg (Low Dose)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1467335 15 mg (Medium Dose)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 1467335 20 mg (High Dose)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 10 mg (Low Dose)
n=9 participants at risk
Participants were orally administered 20 ml solution containing 10 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 15 mg (Medium Dose)
n=9 participants at risk
Participants were orally administered 30 ml solution containing 15 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
BI 1467335 20 mg (High Dose)
n=9 participants at risk
Participants were orally administered 40 ml solution containing 20 mg of BI 1467335: (0.5 mg/ml) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
2/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
General disorders
Fatigue
|
22.2%
2/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
General disorders
Vessel puncture site haematoma
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
33.3%
3/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
33.3%
3/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
33.3%
3/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Psychiatric disorders
Apathy
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.
Treated set (TS): All participants who received at least 1 dose of trial medication.
|
Additional Information
Boehringer Ingelheim, Call Center
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