Trial Outcomes & Findings for This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated (NCT NCT03159455)
NCT ID: NCT03159455
Last Updated: 2021-06-04
Results Overview
Percentage of subjects with investigator-defined drug-related Adverse Events (AEs) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From first day of trial medication intake until end of trial, up to 48 days.
Results posted on
2021-06-04
Participant Flow
This trial was randomised, double-blind, and placebo-controlled within dose groups. There were 3 sequential dose groups and the highest dose group consisted of 2 ethnic subgroups (Japanese and Caucasian ethnicity).
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 |
Placebo (Japanese)
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
3
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Japanese)
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated
Baseline characteristics by cohort
| Measure |
Placebo (Japanese)
n=9 Participants
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
n=3 Participants
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
n=9 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 Years
STANDARD_DEVIATION 5.78 • n=5 Participants
|
32.8 Years
STANDARD_DEVIATION 7.16 • n=7 Participants
|
25.0 Years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
25.3 Years
STANDARD_DEVIATION 2.92 • n=4 Participants
|
31.3 Years
STANDARD_DEVIATION 5.86 • n=21 Participants
|
33.7 Years
STANDARD_DEVIATION 5.92 • n=10 Participants
|
29.5 Years
STANDARD_DEVIATION 6.60 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From first day of trial medication intake until end of trial, up to 48 days.Population: Treated Set (TS): All subjects who received at least 1 dose of trial medication.
Percentage of subjects with investigator-defined drug-related Adverse Events (AEs) is reported.
Outcome measures
| Measure |
Placebo (Japanese)
n=9 Participants
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
n=3 Participants
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
n=9 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug-related Adverse Events
|
22.2 Percentage of subjects
|
33.3 Percentage of subjects
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
11.1 Percentage of subjects
|
SECONDARY outcome
Timeframe: At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.Population: Pharmacokinetic Set (PKS): This subject set included all subjects of the TS who provide at least 1 pharmacokinetic (PK) parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability.
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 (AUC0-24).
Outcome measures
| Measure |
Placebo (Japanese)
n=9 Participants
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=8 Participants
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=7 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
AUC0-24
|
0.898 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 69.4
|
2.05 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 31.4
|
14.7 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 66.9
|
6.39 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 33.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.Population: PKS
Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).
Outcome measures
| Measure |
Placebo (Japanese)
n=9 Participants
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
Cmax
|
0.791 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 60.3
|
1.71 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 53.9
|
8.27 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 64.5
|
3.42 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 55.8
|
—
|
—
|
SECONDARY outcome
Timeframe: At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.Population: PKS
Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of 28th dose (AUC0-24,28).
Outcome measures
| Measure |
Placebo (Japanese)
n=9 Participants
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=8 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
AUC0-24,28
|
21.4 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 51.1
|
117 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 33.7
|
1120 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 24.1
|
721 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 86.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.Population: PKS
Maximum measured concentration of BI 1467335 in plasma following administration of 28th dose (Cmax,28).
Outcome measures
| Measure |
Placebo (Japanese)
n=9 Participants
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=9 Participants
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=8 Participants
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
Cmax,28
|
13.2 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 58.4
|
57.2 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 35.1
|
159 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 19.9
|
124 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 41.8
|
—
|
—
|
Adverse Events
Placebo (Japanese)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1467335 3 mg Tablet (Japanese)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1467335 6 mg Tablet (Japanese)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1467335 10 mg Tablet (Japanese)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (Caucasian)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 1467335 10 mg Tablet (Caucasian)
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 |
Placebo (Japanese)
n=9 participants at risk
Subjects were orally administered matching placebo tablets with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h) in Japanese ethnicity.
|
BI 1467335 3 mg Tablet (Japanese)
n=9 participants at risk
Subjects were orally administered BI 1467335 3 milligram (mg) film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 6 mg Tablet (Japanese)
n=9 participants at risk
Subjects were orally administered BI 1467335 6 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
BI 1467335 10 mg Tablet (Japanese)
n=9 participants at risk
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Japanese ethnicity.
|
Placebo (Caucasian)
n=3 participants at risk
Subjects were orally administered matching placebo tablets with 240 mL water after an overnight fast of at least 10 h in Caucasian ethnicity.
|
BI 1467335 10 mg Tablet (Caucasian)
n=9 participants at risk
Subjects were orally administered BI 1467335 10 mg film-coated tablets once daily with 240 mL water after an overnight fast of at least 10 h for 28 days in Caucasian ethnicity.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
33.3%
3/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Eye disorders
Keratitis
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
33.3%
3/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
22.2%
2/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
11.1%
1/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/3 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects who received at least 1 dose of trial medication.
|
0.00%
0/9 • From first day of trial medication intake until end of trial, up to 48 days.
Treated Set (TS): All subjects 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