Trial Outcomes & Findings for A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080 (NCT NCT04666922)
NCT ID: NCT04666922
Last Updated: 2024-02-23
Results Overview
Percentage of subjects with drug-related adverse events is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Up to 87 days
Results posted on
2024-02-23
Participant Flow
This is a Phase I, single-blind, randomized, placebo-controlled, parallel-group design trial to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.
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 |
1 mg BI 765080 Group
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
1 mg BI 765080 Group
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080
Baseline characteristics by cohort
| Measure |
1 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
n=12 Participants
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
33.7 Years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
31.2 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
38.3 Years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
32.3 Years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
37.5 Years
STANDARD_DEVIATION 11.3 • n=8 Participants
|
32.8 Years
STANDARD_DEVIATION 6.6 • n=8 Participants
|
35.1 Years
STANDARD_DEVIATION 8.0 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
47 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 87 daysPopulation: Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug.
Percentage of subjects with drug-related adverse events is presented.
Outcome measures
| Measure |
1 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
n=12 Participants
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug-related Adverse Events
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability (as specified below). Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of BI 765080 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.
Outcome measures
| Measure |
1 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
n=5 Participants
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 765080 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
4950 hours*nanograms/milliLitres (h*ng/mL)
Geometric Coefficient of Variation 48.4
|
258000 hours*nanograms/milliLitres (h*ng/mL)
Geometric Coefficient of Variation 20.6
|
973000 hours*nanograms/milliLitres (h*ng/mL)
Geometric Coefficient of Variation 16.2
|
2530000 hours*nanograms/milliLitres (h*ng/mL)
Geometric Coefficient of Variation 39.9
|
7180000 hours*nanograms/milliLitres (h*ng/mL)
Geometric Coefficient of Variation 24.7
|
14900000 hours*nanograms/milliLitres (h*ng/mL)
Geometric Coefficient of Variation 21.8
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability (as specified below). Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of BI 765080 in serum (Cmax) is presented.
Outcome measures
| Measure |
1 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
n=5 Participants
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
n=6 Participants
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 765080 in Serum (Cmax)
|
274 nanograms/milliLitres (ng/mL)
Geometric Coefficient of Variation 21.4
|
3490 nanograms/milliLitres (ng/mL)
Geometric Coefficient of Variation 11.0
|
8230 nanograms/milliLitres (ng/mL)
Geometric Coefficient of Variation 14.9
|
16900 nanograms/milliLitres (ng/mL)
Geometric Coefficient of Variation 29.0
|
35400 nanograms/milliLitres (ng/mL)
Geometric Coefficient of Variation 13.7
|
64500 nanograms/milliLitres (ng/mL)
Geometric Coefficient of Variation 11.6
|
—
|
Adverse Events
1 mg BI 765080 Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 mg BI 765080 Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
25 mg BI 765080 Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 mg BI 765080 Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
100 mg BI 765080 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg BI 765080 Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Group
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 |
1 mg BI 765080 Group
n=6 participants at risk
Subjects received a single dose of 1 milligram (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
10 mg BI 765080 Group
n=6 participants at risk
Subjects received a single dose of 10 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
25 mg BI 765080 Group
n=6 participants at risk
Subjects received a single dose of 25 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
50 mg BI 765080 Group
n=6 participants at risk
Subjects received a single dose of 50 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
100 mg BI 765080 Group
n=6 participants at risk
Subjects received a single dose of 100 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
200 mg BI 765080 Group
n=6 participants at risk
Subjects received a single dose of 200 milligrams (mg) BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
Placebo Group
n=12 participants at risk
Subjects received a single dose of placebo matching BI 765080 as a 30 minutes (min) intravenous infusion on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
33.3%
2/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Infections and infestations
Tooth abscess
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Infections and infestations
Herpes zoster reactivation
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
General disorders
Reactogenicity event
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
16.7%
1/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Investigations
Weight increased
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
0.00%
0/6 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
8.3%
1/12 • From first drug administration till end of trial, up to 87 days.
Treated set (TS): all subjects who were randomized and treated with at least one dose of study drug. It was used for safety analyses.
|
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