Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers (NCT NCT01841112)
NCT ID: NCT01841112
Last Updated: 2024-06-25
Results Overview
Percentage (%) of subjects with drug-related adverse events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
From first drug administration until 11 days after last dose of study medication, up to 18 days.
Results posted on
2024-06-25
Participant Flow
This was randomised, placebo controlled and double-blind within dose groups, single dose (3 dose groups), multiple dose (1 dose group, 8-day treatment), single centre trial with healthy Chinese and Japanese male volunteers
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
|
|---|---|---|---|---|---|
|
Single Dose Segment (Day 1)
STARTED
|
16
|
12
|
12
|
19
|
6
|
|
Single Dose Segment (Day 1)
COMPLETED
|
15
|
11
|
11
|
19
|
6
|
|
Single Dose Segment (Day 1)
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
|
Washout (48 Hours)
STARTED
|
0
|
0
|
0
|
0
|
6
|
|
Washout (48 Hours)
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
|
Washout (48 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Multiple Dose Segment (Days3-9)
STARTED
|
0
|
0
|
0
|
0
|
6
|
|
Multiple Dose Segment (Days3-9)
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
|
Multiple Dose Segment (Days3-9)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
|
|---|---|---|---|---|---|
|
Single Dose Segment (Day 1)
Not Treated
|
1
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=11 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
n=11 Participants
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
n=19 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.9 Years
STANDARD_DEVIATION 3.1 • n=99 Participants
|
26.5 Years
STANDARD_DEVIATION 4.0 • n=107 Participants
|
26.6 Years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
27.4 Years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
26.3 Years
STANDARD_DEVIATION 2.9 • n=31 Participants
|
26.4 Years
STANDARD_DEVIATION 4.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
62 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
62 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Poor metaboliser (PM) / extensive metaboliser (EM)
Poor metaboliser (PM)
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Poor metaboliser (PM) / extensive metaboliser (EM)
Extensive metaboliser (EM)
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
46 Participants
n=30 Participants
|
|
Ethnicity
Chinese
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
32 Participants
n=30 Participants
|
|
Ethnicity
Japanese
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until 11 days after last dose of study medication, up to 18 days.Population: Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
Percentage (%) of subjects with drug-related adverse events (AEs).
Outcome measures
| Measure |
Placebo
n=15 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=11 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
n=11 Participants
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
n=19 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
n=6 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage (%) of Subjects With Drug-related Adverse Events (AEs)
|
13.3 Percentage of Participants
|
9.1 Percentage of Participants
|
36.4 Percentage of Participants
|
57.9 Percentage of Participants
|
83.3 Percentage of Participants
|
83.3 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints.
Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax).
Outcome measures
| Measure |
Placebo
n=5 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
n=7 Participants
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
n=6 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
n=5 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
n=6 Participants
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax)
|
292 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 113.0
|
824 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 74.1
|
1970 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 77.8
|
4020 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 26.8
|
496 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 26.5
|
914 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 32.5
|
3290 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 43.0
|
4510 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 26.8
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. Only subjects with non missing values were included in the endpoint.
Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).
Outcome measures
| Measure |
Placebo
n=5 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=5 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
n=7 Participants
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
n=6 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
n=5 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
n=6 Participants
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
|
376 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 67.7
|
1070 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 119.0
|
2020 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 106.0
|
7550 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 21.4
|
504 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 24.7
|
985 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 40.3
|
2100 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 47.1
|
8650 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 32.1
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints.
Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Placebo
n=5 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
n=7 Participants
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
n=6 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
n=5 Participants
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
n=6 Participants
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
n=6 Participants
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz)
|
375 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 67.8
|
1040 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 102.0
|
2020 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 106.0
|
7550 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 21.4
|
504 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 24.8
|
985 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 40.3
|
2100 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 47.1
|
8640 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 32.1
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups.
Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax)
|
926 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 30.9
|
1080 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups.
Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax)
|
3800 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 21.8
|
4340 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups.
Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
|
1650 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 14.2
|
1520 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups.
Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
|
8670 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 10.8
|
9060 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 14.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups.
Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
|
1650 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 14.2
|
1510 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.Population: The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups.
Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=6 Participants
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg MD-PM
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
BI-409306 100 mg SD-PM
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg - Japanese
6 Japanese EM subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD & MD - Japanese (PM)
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.
For the current endpoint only data collected following the first dose were considered.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
|
8670 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 10.8
|
9060 nanomol (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 14.6
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI-409306 25 Milligram (mg) SD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI-409306 50 mg SD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI-409306 100 mg SD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BI-409306 100 mg SD-PM
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI-409306 100 mg MD-PM
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
n=15 participants at risk
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
|
BI-409306 25 Milligram (mg) SD
n=11 participants at risk
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 50 mg SD
n=11 participants at risk
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD
n=19 participants at risk
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
|
BI-409306 100 mg SD-PM
n=6 participants at risk
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment
|
BI-409306 100 mg MD-PM
n=6 participants at risk
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
18.2%
2/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
5.3%
1/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Eye disorders
Asthenopia
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
21.1%
4/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Eye disorders
Photophobia
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
15.8%
3/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Eye disorders
Photopsia
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
26.3%
5/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
33.3%
2/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
33.3%
2/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
16.7%
1/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
5.3%
1/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
9.1%
1/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
|
General disorders
Feeling hot
|
0.00%
0/15 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/11 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
5.3%
1/19 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
0.00%
0/6 • From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER