Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (NCT NCT01594515)
NCT ID: NCT01594515
Last Updated: 2015-12-15
Results Overview
Percentage of subjects with drug related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Results posted on
2015-12-15
Participant Flow
70 patients were treated and analysed.
Partially randomised, placebo-controlled within dose groups, single-blinded, single-centre study to assess the safety, tolerability and pk of single rising oral doses of BI 1015550(a powder for oral solution reconstituted with solvent tartaric acid and solvent component hydroxy-propyl-β-cyclodextrin (HPβCD)) in healthy male volunteers.
Participant milestones
| Measure |
BI 1015550 Low Dose 0.02mg
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 Years
STANDARD_DEVIATION 5.1 • n=93 Participants
|
29.5 Years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
38.2 Years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
35.0 Years
STANDARD_DEVIATION 5.5 • n=483 Participants
|
35.5 Years
STANDARD_DEVIATION 5.9 • n=36 Participants
|
32.7 Years
STANDARD_DEVIATION 5.9 • n=10 Participants
|
36.3 Years
STANDARD_DEVIATION 6.3 • n=115 Participants
|
40.5 Years
STANDARD_DEVIATION 3.3 • n=40 Participants
|
33.5 Years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
36.6 Years
STANDARD_DEVIATION 5.6 • n=62 Participants
|
35.3 Years
STANDARD_DEVIATION 6.1 • n=95 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
16 Participants
n=62 Participants
|
70 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
Percentage of subjects with drug related adverse events.
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Drug Related Adverse Events
|
0.0 Percentage of Participants
|
33.3 Percentage of Participants
|
16.7 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
33.3 Percentage of Participants
|
16.7 Percentage of Participants
|
16.7 Percentage of Participants
|
16.7 Percentage of Participants
|
6.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
Percentage of subjects with clinically relevant abnormalities in physical examinations.
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
n=16 Participants
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.
Maximum measured concentration of the analyte in plasma.
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of BI 1015550
|
NA nmol/L
Geometric Coefficient of Variation NA
Not calculated because BI 1015550 was below the detection limit
|
1.42 nmol/L
Geometric Coefficient of Variation 23.2
|
5.02 nmol/L
Geometric Coefficient of Variation 20.1
|
13.7 nmol/L
Geometric Coefficient of Variation 14.2
|
46.9 nmol/L
Geometric Coefficient of Variation 38.9
|
113 nmol/L
Geometric Coefficient of Variation 20.4
|
176 nmol/L
Geometric Coefficient of Variation 12.6
|
292 nmol/L
Geometric Coefficient of Variation 22.2
|
542 nmol/L
Geometric Coefficient of Variation 12.1
|
—
|
SECONDARY outcome
Timeframe: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosingPopulation: The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
BI 1015550 Low Dose 0.02mg
n=6 Participants
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 Participants
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 Participants
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 Participants
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 Participants
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 Participants
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 Participants
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 Participants
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 Participants
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
Placebo
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-infinity of BI 1015550
|
NA nmol*h/L
Geometric Coefficient of Variation NA
Not calculated because BI 1015550 was below the detection limit
|
7.44 nmol*h/L
Geometric Coefficient of Variation 12.7
|
24.1 nmol*h/L
Geometric Coefficient of Variation 13.9
|
67.9 nmol*h/L
Geometric Coefficient of Variation 15.6
|
287 nmol*h/L
Geometric Coefficient of Variation 14.9
|
679 nmol*h/L
Geometric Coefficient of Variation 32.0
|
1210 nmol*h/L
Geometric Coefficient of Variation 18.3
|
2180 nmol*h/L
Geometric Coefficient of Variation 19.9
|
3650 nmol*h/L
Geometric Coefficient of Variation 22.6
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1015550 Low Dose 0.02mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1015550 Low Dose 0.06mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1015550 Low Dose 0.2mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1015550 Low Dose 0.6mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1015550 Medium Dose 2mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1015550 Medium Dose 4mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1015550 Medium Dose 8mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1015550 High Dose 16mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1015550 High Dose 24mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.02mg
n=6 participants at risk
Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.06mg
n=6 participants at risk
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.2mg
n=6 participants at risk
Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Low Dose 0.6mg
n=6 participants at risk
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 2mg
n=6 participants at risk
Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 4mg
n=6 participants at risk
Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 Medium Dose 8mg
n=6 participants at risk
Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 16mg
n=6 participants at risk
Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
BI 1015550 High Dose 24mg
n=6 participants at risk
Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
General disorders
Application site irritation
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
General disorders
Fatigue
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
33.3%
2/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
33.3%
2/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
16.7%
1/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
0.00%
0/6 • From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
|
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
- Publication restrictions are in place