Trial Outcomes & Findings for This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood. (NCT NCT03483077)
NCT ID: NCT03483077
Last Updated: 2022-08-10
Results Overview
Percentages are calculated using total number of participants per treatment as the denominator. MedDRA version used for reporting: 22.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From drug administration until end of trial, up to 13 days.
Results posted on
2022-08-10
Participant Flow
The evaluation of single-rising dose (SRD) of BI 730460 was designed as a partially randomised, single-blind, placebo-controlled trial and the evaluation of bioavailability of BI 730460 with and without food was designed as a randomised, open-label, single-dose, two-way cross-over trial.
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 Matching BI 730460
Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
2 Milligram (mg) - BI 730460
A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
8 mg - BI 730460
A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
25 mg - BI 730460
A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
50 mg - BI 730460
A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
100 mg - BI 730460
A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
200 mg - BI 730460
A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 730460
n=12 Participants
Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
2 Milligram (mg) - BI 730460
n=6 Participants
A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
8 mg - BI 730460
n=6 Participants
A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
25 mg - BI 730460
n=6 Participants
A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
50 mg - BI 730460
n=6 Participants
A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
100 mg - BI 730460
n=6 Participants
A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
200 mg - BI 730460
n=6 Participants
A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.0 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
36.0 Years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
30.3 Years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
30.7 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
34.7 Years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
30.5 Years
STANDARD_DEVIATION 4.7 • n=8 Participants
|
33.7 Years
STANDARD_DEVIATION 7.9 • n=8 Participants
|
32.7 Years
STANDARD_DEVIATION 6.6 • 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
|
12 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
|
6 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 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
|
6 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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)
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
|
12 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
|
6 Participants
n=8 Participants
|
48 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: From drug administration until end of trial, up to 13 days.Population: Treated set: Participants who received at least 1 dose of trial drug.
Percentages are calculated using total number of participants per treatment as the denominator. MedDRA version used for reporting: 22.0.
Outcome measures
| Measure |
Placebo Matching BI 730460
n=12 Participants
Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
2 Milligram (mg) - BI 730460
n=6 Participants
A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
8 mg - BI 730460
n=6 Participants
A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
25 mg - BI 730460
n=6 Participants
A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
50 mg - BI 730460
n=6 Participants
A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
100 mg - BI 730460
n=6 Participants
A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
200 mg - BI 730460
n=6 Participants
A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events
|
8.3 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
16.7 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to drug administration followed by 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 34.0, 48.0, 72.0, 96.0, 168.0 hours post drug administration.Population: Pharmacokinetic analysis set: Participants from the treated set receiving BI 730460 who provided at least 1 secondary pharmacokinetic parameter that was not excluded.
Area under the concentration-time curve of BI 730460 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
Placebo Matching BI 730460
n=6 Participants
Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
2 Milligram (mg) - BI 730460
n=6 Participants
A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
8 mg - BI 730460
n=6 Participants
A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
25 mg - BI 730460
n=6 Participants
A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
50 mg - BI 730460
n=6 Participants
A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
100 mg - BI 730460
n=6 Participants
A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
200 mg - BI 730460
A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 730460 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
557 Nanomol*hour per litre
Geometric Coefficient of Variation 35.4
|
2540 Nanomol*hour per litre
Geometric Coefficient of Variation 41.2
|
5610 Nanomol*hour per litre
Geometric Coefficient of Variation 25.4
|
11200 Nanomol*hour per litre
Geometric Coefficient of Variation 56.8
|
31500 Nanomol*hour per litre
Geometric Coefficient of Variation 23.8
|
47600 Nanomol*hour per litre
Geometric Coefficient of Variation 36.1
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to drug administration followed by 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 34.0, 48.0, 72.0, 96.0, 168.0 hours post drug administration.Population: Pharmacokinetic analysis set: Participants from the treated set who received BI 730460 and provided at least 1 secondary pharmacokinetic parameter that was not excluded.
Maximum measured concentration of BI 730460 in plasma (Cmax).
Outcome measures
| Measure |
Placebo Matching BI 730460
n=6 Participants
Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
2 Milligram (mg) - BI 730460
n=6 Participants
A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
8 mg - BI 730460
n=6 Participants
A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
25 mg - BI 730460
n=6 Participants
A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
50 mg - BI 730460
n=6 Participants
A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
100 mg - BI 730460
n=6 Participants
A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
200 mg - BI 730460
A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 730460 in Plasma
|
31.8 nanomol per litre
Geometric Coefficient of Variation 23.2
|
140 nanomol per litre
Geometric Coefficient of Variation 34.0
|
1860 nanomol per litre
Geometric Coefficient of Variation 23.8
|
309 nanomol per litre
Geometric Coefficient of Variation 11.8
|
597 nanomol per litre
Geometric Coefficient of Variation 22.6
|
1470 nanomol per litre
Geometric Coefficient of Variation 32.2
|
—
|
Adverse Events
Placebo Matching BI 730460
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
2 Milligram (mg) - BI 730460
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8 mg - BI 730460
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
25 mg - BI 730460
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg - BI 730460
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg - BI 730460
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200 mg - BI 730460
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total on Treatment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Matching BI 730460
n=12 participants at risk
Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
2 Milligram (mg) - BI 730460
n=6 participants at risk
A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
8 mg - BI 730460
n=6 participants at risk
A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
25 mg - BI 730460
n=6 participants at risk
A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
50 mg - BI 730460
n=6 participants at risk
A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
100 mg - BI 730460
n=6 participants at risk
A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
200 mg - BI 730460
n=6 participants at risk
A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
|
Total on Treatment
n=48 participants at risk
Total over all on treatment phases included in this analysis
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Haematochezia
|
8.3%
1/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
General disorders
Medical device site reaction
|
8.3%
1/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
4.2%
2/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Infections and infestations
Rhinitis
|
16.7%
2/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
4.2%
2/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
6.2%
3/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
4.2%
2/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
2.1%
1/48 • Adverse events were collected from drug administration till end of trial, up to 13 days
Treated Set (TS): Participants who received at least 1 dose of trial drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place