Trial Outcomes & Findings for A Study in Healthy Men to Test the Effects of Different Doses of BI 1467335 on MAO-B Activity in the Brain. (NCT NCT03927209)
NCT ID: NCT03927209
Last Updated: 2021-06-22
Results Overview
The primary endpoint of the trial was the percent reduction in whole brain MAO-B availability, as assessed by PET imaging, on the last day of treatment with BI 1467335 (Day 28 for the 10 mg dose group and Day 42 for the 3 mg dose group) compared with baseline. Image analysis was used to generate the outcome parameter for the PET data (proportional to the target availability at each PET scan) using the PET emission and the metabolite corrected arterial plasma input function in an appropriate kinetic model.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Baseline (day -14 to -2) and last day of treatment (Day 28 for the 10 mg dose group and Day 42 for the 3 mg dose group).
Results posted on
2021-06-22
Participant Flow
This phase I trial was conducted using a non-randomised, non-controlled, open-label, parallel-group, multiple-dose design.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 1467335 10 Milligram (mg)
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test the Effects of Different Doses of BI 1467335 on MAO-B Activity in the Brain.
Baseline characteristics by cohort
| Measure |
BI 1467335 10 Milligram (mg)
n=5 Participants
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
n=5 Participants
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
39.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
41.4 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (day -14 to -2) and last day of treatment (Day 28 for the 10 mg dose group and Day 42 for the 3 mg dose group).Population: PET set (PETS): This set included all subjects who were randomized and treated with at least one dose of study drug for whom at least 1 PET scan at baseline and 1 on-treatment scan were provided.
The primary endpoint of the trial was the percent reduction in whole brain MAO-B availability, as assessed by PET imaging, on the last day of treatment with BI 1467335 (Day 28 for the 10 mg dose group and Day 42 for the 3 mg dose group) compared with baseline. Image analysis was used to generate the outcome parameter for the PET data (proportional to the target availability at each PET scan) using the PET emission and the metabolite corrected arterial plasma input function in an appropriate kinetic model.
Outcome measures
| Measure |
BI 1467335 10 Milligram (mg)
n=5 Participants
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
n=4 Participants
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
|---|---|---|
|
Percentage Reduction in Whole Brain Monoamine Oxidase (MAO)-B Availability Assessed by Positron Emission Tomography (PET) Imaging
|
72.58 Percent reduction
Standard Deviation 11.81
|
2.43 Percent reduction
Standard Deviation 6.05
|
SECONDARY outcome
Timeframe: Baseline (day -14 to -2) and Day 14 of treatment.Population: PET set (PETS): This set included all subjects who were randomized and treated with at least one dose of study drug for whom at least 1 PET scan at baseline and 1 on-treatment scan were provided
Percent reduction in MAO-B availability on Day 14 of treatment with 10 mg BI 1467335 compared with baseline. Image analysis was used to generate the outcome parameter for the PET data (proportional to the target availability at each PET scan) using the PET emission and the metabolite corrected arterial plasma input function in an appropriate kinetic model.
Outcome measures
| Measure |
BI 1467335 10 Milligram (mg)
n=5 Participants
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
|---|---|---|
|
Percent Reduction in MAO-B Availability on Day 14 of Treatment With 10 mg BI 1467335 Compared With Baseline
|
44.56 Percent reduction
Standard Deviation 16.20
|
—
|
SECONDARY outcome
Timeframe: Baseline (day -14 to -2) and Day 28 of treatment.Population: PET set (PETS): This set included all subjects who were randomized and treated with at least one dose of study drug for whom at least 1 PET scan at baseline and 1 on-treatment scan were provided. One subject in the 3 mg dose group was excluded from the PET analysis because had no measurement of MAO-B availability on Day 28.
Reduction in MAO-B availability on Day 28 of treatment with 3 mg BI 1467335 compared with baseline. Image analysis was used to generate the outcome parameter for the PET data (proportional to the target availability at each PET scan) using the PET emission and the metabolite corrected arterial plasma input function in an appropriate kinetic model.
Outcome measures
| Measure |
BI 1467335 10 Milligram (mg)
n=3 Participants
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
|---|---|---|
|
Reduction in MAO-B Availability on Day 28 of Treatment With 3 mg BI 1467335 Compared With Baseline
|
-1.43 Percent reduction
Standard Deviation 6.29
|
—
|
SECONDARY outcome
Timeframe: Baseline (day -14 to -2) and last day of treatment (Day 28 for the 10 mg dose group and Day 42 for the 3 mg dose group).Population: Due to missing baseline values, processing errors and errors in the conduct of the analytical assay most subjects were excluded. The small amount of available data precluded accurate evaluation of the pharmacokinetic - pharmacodynamic (PK-PD) relationship.
MAO-B activity in plasma was assessed after 14 days of dosing with BI 1467335 (10 mg dose group only), 28 days of dosing (10 and 3 mg dose groups), and 42 days of dosing (3 mg dose group only).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 3 hours (h) before and 20 minutes (min), 45 min, 1h, 1h 30 min, 3h, 4h, 7h, 11h, 24h (~30 min before next scheduled dosing where applicable) after administration of BI 1467335.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS for whom at least 1 PK endpoint was provided, and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 1467335 in Plasma (Cmax).
Outcome measures
| Measure |
BI 1467335 10 Milligram (mg)
n=5 Participants
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
n=5 Participants
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1467335 in Plasma
Day 14
|
36.4 nanomol per liter
Geometric Coefficient of Variation 65.2
|
—
|
|
Maximum Measured Concentration of BI 1467335 in Plasma
Day 28
|
48.4 nanomol per liter
Geometric Coefficient of Variation 85.3
|
2.28 nanomol per liter
Geometric Coefficient of Variation 76.0
|
|
Maximum Measured Concentration of BI 1467335 in Plasma
Day 42
|
—
|
3.60 nanomol per liter
Geometric Coefficient of Variation 146
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before and 20 minutes (min), 45 min, 1h, 1h 30 min, 3h, 4h, 7h, 11h, 24h (~30 min before next scheduled dosing where applicable) after administration of BI 1467335.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS for whom at least 1 PK endpoint was provided, and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time 24 h.
Outcome measures
| Measure |
BI 1467335 10 Milligram (mg)
n=5 Participants
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
n=5 Participants
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time 24 h (AUC 0-24)
Day 28
|
235 nanomol * hours per liter
Geometric Coefficient of Variation 148.0
|
4.65 nanomol * hours per liter
Geometric Coefficient of Variation 54.9
|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time 24 h (AUC 0-24)
Day 42
|
—
|
4.34 nanomol * hours per liter
Geometric Coefficient of Variation 132
|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time 24 h (AUC 0-24)
Day 14
|
85.7 nanomol * hours per liter
Geometric Coefficient of Variation 75.5
|
—
|
Adverse Events
BI 1467335 10 Milligram (mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1467335 3 Milligram (mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Total on Treatment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1467335 10 Milligram (mg)
n=5 participants at risk
Oral administration of 10 milligram (mg) BI 1467335 (2 film-coated tablet of 5 mg) per day for 28 days together with 240 milliliter (mL) of water.
|
BI 1467335 3 Milligram (mg)
n=5 participants at risk
Oral administration of 3 milligram (mg) BI 1467335 (3 film-coated tablet of 1 mg) per day for 42 days together with 240 milliliter (mL) of water.
|
Total on Treatment
n=10 participants at risk
Total of the over all on-treatment phases of BI 1467335.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site bruise
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
2/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Fatigue
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Feeling hot
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Injury
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/5 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
10.0%
1/10 • From the date/time of first administration of BI 1467335 until 12 a.m. on the day after subjects end of participation date. (Up to 36 days for 10mg group, up to 50 days for 3mg group)
Treated set (TS): The TS included all subjects who were randomized and treated with at least one dose of study drug.
|
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