Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306 (NCT NCT01611311)
NCT ID: NCT01611311
Last Updated: 2024-03-08
Results Overview
Percentage of subjects with investigator defined drug-related Adverse Events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Results posted on
2024-03-08
Participant Flow
Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 409306 film-coated tablets given orally once daily (q.d.) for 14 days in young and elderly healthy male/female volunteers (randomized, double-blind, placebo controlled within dose groups Phase I study).All young subjects were Poor Metabolizer for CYP2C19
All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be entered to trial if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
Placebo (Young Subjects)
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
6
|
6
|
9
|
9
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
6
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
Placebo (Young Subjects)
n=4 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=6 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Young subjects
|
23.8 Years
STANDARD_DEVIATION 3.0 • n=4 Participants • Treated Set
|
34.7 Years
STANDARD_DEVIATION 7.7 • n=6 Participants • Treated Set
|
30.8 Years
STANDARD_DEVIATION 10.2 • n=6 Participants • Treated Set
|
—
|
—
|
—
|
30.5 Years
STANDARD_DEVIATION 8.7 • n=16 Participants • Treated Set
|
|
Age, Continuous
Elderly subjects
|
—
|
—
|
—
|
70.8 Years
STANDARD_DEVIATION 3.4 • n=6 Participants • Treated Set
|
69.9 Years
STANDARD_DEVIATION 3.1 • n=9 Participants • Treated Set
|
68.1 Years
STANDARD_DEVIATION 2.4 • n=9 Participants • Treated Set
|
69.5 Years
STANDARD_DEVIATION 3.1 • n=24 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants • Treated Set
|
1 Participants
n=6 Participants • Treated Set
|
2 Participants
n=6 Participants • Treated Set
|
2 Participants
n=6 Participants • Treated Set
|
5 Participants
n=9 Participants • Treated Set
|
4 Participants
n=9 Participants • Treated Set
|
17 Participants
n=40 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants • Treated Set
|
5 Participants
n=6 Participants • Treated Set
|
4 Participants
n=6 Participants • Treated Set
|
4 Participants
n=6 Participants • Treated Set
|
4 Participants
n=9 Participants • Treated Set
|
5 Participants
n=9 Participants • Treated Set
|
23 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=4 Participants • Treated Set
|
5 Participants
n=6 Participants • Treated Set
|
5 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
14 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants • Treated Set
|
1 Participants
n=6 Participants • Treated Set
|
1 Participants
n=6 Participants • Treated Set
|
6 Participants
n=6 Participants • Treated Set
|
9 Participants
n=9 Participants • Treated Set
|
9 Participants
n=9 Participants • Treated Set
|
26 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=40 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=6 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=9 Participants • Treated Set
|
0 Participants
n=40 Participants • Treated Set
|
PRIMARY outcome
Timeframe: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 daysPopulation: The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
Percentage of subjects with investigator defined drug-related Adverse Events (AEs).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=4 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=6 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Investigator Defined Drug-Related Adverse Events
|
50.0 Percentage of subjects
|
50.0 Percentage of subjects
|
66.7 Percentage of subjects
|
50.0 Percentage of subjects
|
55.6 Percentage of subjects
|
44.4 Percentage of subjects
|
PRIMARY outcome
Timeframe: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 daysPopulation: The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.
Outcome measures
| Measure |
Placebo (Young Subjects)
n=4 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=6 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Visual acuity test
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Color discrimination test
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Suicidality assessment
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Physical examination
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
12-lead electrocardiogram (ECG)
|
25.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Blood pressure and pulse rate
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Orthostatic intolerance
|
25.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
33.3 Percentage of subjects with findings
|
33.3 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
|
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Clinical laboratory tests
|
0.0 Percentage of subjects with findings
|
16.6 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
0.0 Percentage of subjects with findings
|
11.1 Percentage of subjects with findings
|
SECONDARY outcome
Timeframe: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
Maximum measured concentration of the BI 409306 in plasma (Cmax).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=6 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=9 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
|
679 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 44.1
|
1310 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 33.9
|
459 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 55.2
|
768 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 55.3
|
—
|
—
|
SECONDARY outcome
Timeframe: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=6 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=9 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)
|
694 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 33.1
|
1740 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 29.8
|
516 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 51.2
|
872 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 56.3
|
—
|
—
|
SECONDARY outcome
Timeframe: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
Area under the concentration-time curve of the BI 409306 in plasma from 0 to 24 hours (AUC0-24).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=6 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=9 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)
|
1570 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 33.5
|
2690 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 50.2
|
622 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 72.6
|
1030 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 42.1
|
—
|
—
|
SECONDARY outcome
Timeframe: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=6 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=9 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
|
1800 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 29.7
|
3410 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 40.8
|
682 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 58.9
|
1250 Nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 50.1
|
—
|
—
|
SECONDARY outcome
Timeframe: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=6 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=9 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)
|
0.625 hours
Interval 0.333 to 1.5
|
0.750 hours
Interval 0.333 to 1.0
|
0.500 hours
Interval 0.333 to 0.75
|
0.500 hours
Interval 0.167 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss).
Outcome measures
| Measure |
Placebo (Young Subjects)
n=6 Participants
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 Participants
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=9 Participants
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=9 Participants
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss)
|
0.634 hours
Interval 0.5 to 1.5
|
0.417 hours
Interval 0.333 to 0.75
|
0.333 hours
Interval 0.333 to 0.55
|
0.367 hours
Interval 0.167 to 0.517
|
—
|
—
|
Adverse Events
Placebo (Young Subjects)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Elderly Subjects)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 409306 - 25 Milligram (mg) (Young Subjects)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 409306 - 50 Milligram (mg) (Young Subjects)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Young Subjects)
n=4 participants at risk
Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
Placebo (Elderly Subjects)
n=6 participants at risk
Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Young Subjects)
n=6 participants at risk
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Young Subjects)
n=6 participants at risk
Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 25 Milligram (mg) (Elderly Subjects)
n=9 participants at risk
Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
BI 409306 - 50 Milligram (mg) (Elderly Subjects)
n=9 participants at risk
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
25.0%
1/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
33.3%
3/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Photophobia
|
25.0%
1/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
33.3%
2/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
50.0%
3/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
22.2%
2/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
50.0%
3/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
33.3%
3/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
33.3%
3/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Orthostatic intolerance
|
25.0%
1/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
33.3%
2/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
33.3%
3/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
11.1%
1/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
0.00%
0/9 • From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
|
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