Trial Outcomes & Findings for A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood (NCT NCT03794323)
NCT ID: NCT03794323
Last Updated: 2023-05-01
Results Overview
Percentage of subjects with drug-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
76 participants
Primary outcome timeframe
From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Results posted on
2023-05-01
Participant Flow
The trial investigated safety, tolerability and pharmacokinetics of single rising doses (SRD) of BI 764122 (partially randomized, placebo-controlled, single-blind, parallel (sequential) group design) and its food effect (FE) (randomized, open-label, single-dose, 2-period, 2-sequence crossover design).
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
placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
4 mg BI 764122
4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
12 mg BI 764122
1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
25 mg BI 764122
2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122
5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
100 mg BI 764122
1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
200 mg BI 764122
2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
300 mg BI 764122
3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
400 mg BI 764122
4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
BI 764122 50 mg Fasted/ BI 764122 50 mg Fed
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
|
BI 764122 50 mg Fed/ BI 764122 50 mg Fasted
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after an overnight fast of at least 10 h. FE part.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (SRD and FE Parts)
STARTED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Treatment Period 1 (SRD and FE Parts)
COMPLETED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Treatment Period 1 (SRD and FE Parts)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash-out Period (FE Part Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Wash-out Period (FE Part Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Wash-out Period (FE Part Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (FE Part Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Treatment Period 2 (FE Part Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Treatment Period 2 (FE Part Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
4 mg BI 764122
n=6 Participants
4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
12 mg BI 764122
n=6 Participants
1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
25 mg BI 764122
n=6 Participants
2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122
n=6 Participants
5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
100 mg BI 764122
n=6 Participants
1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
200 mg BI 764122
n=6 Participants
2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
300 mg BI 764122
n=6 Participants
3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
400 mg BI 764122
n=6 Participants
4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
BI 764122 50 mg Fasted/ BI 764122 50 mg Fed
n=6 Participants
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
|
BI 764122 50 mg Fed/ BI 764122 50 mg Fasted
n=6 Participants
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after an overnight fast of at least 10 h. FE part.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.4 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
32.0 Years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
38.7 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
32.7 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
35.7 Years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
35.7 Years
STANDARD_DEVIATION 5.8 • n=10 Participants
|
31.8 Years
STANDARD_DEVIATION 7.2 • n=115 Participants
|
33.2 Years
STANDARD_DEVIATION 9.8 • n=24 Participants
|
32.8 Years
STANDARD_DEVIATION 9.4 • n=42 Participants
|
40.8 Years
STANDARD_DEVIATION 10.3 • n=42 Participants
|
36.8 Years
STANDARD_DEVIATION 10.3 • n=42 Participants
|
34.3 Years
STANDARD_DEVIATION 8.9 • n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
16 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=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
76 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
75 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
73 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From drug administration until 11 days thereafter for both single rising doses and food effect parts.Population: Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
Percentage of subjects with drug-related adverse events.
Outcome measures
| Measure |
Placebo
n=16 Participants
placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
4 mg BI 764122
n=6 Participants
4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
12 mg BI 764122
n=6 Participants
1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
25 mg BI 764122
n=6 Participants
2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122
n=6 Participants
5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
100 mg BI 764122
n=6 Participants
1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
200 mg BI 764122
n=6 Participants
2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
300 mg BI 764122
n=6 Participants
3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
400 mg BI 764122
n=6 Participants
4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122 Fasted
n=12 Participants
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 hours. Food effect (FE) part.
|
50 mg BI 764122 Fed
n=12 Participants
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug-related Adverse Events
|
6.3 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
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
8.3 Percentage of participants
|
8.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects from the treated set (TS) who provided data for at least 1 PK endpoint, who were not excluded due to a protocol violation relevant to the evaluation of PK, and who were not excluded due to PK non-evaluability.
Area under the concentration-time curve of BI 764122 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Outcome measures
| Measure |
Placebo
n=6 Participants
placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
4 mg BI 764122
n=6 Participants
4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
12 mg BI 764122
n=6 Participants
1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
25 mg BI 764122
n=6 Participants
2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122
n=6 Participants
5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
100 mg BI 764122
n=6 Participants
1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
200 mg BI 764122
n=6 Participants
2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
300 mg BI 764122
n=6 Participants
3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
400 mg BI 764122
n=12 Participants
4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122 Fasted
n=12 Participants
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 hours. Food effect (FE) part.
|
50 mg BI 764122 Fed
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 764122 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
534 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 19.0
|
1530 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 33.3
|
2850 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 15.1
|
5260 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 23.5
|
9810 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 14.1
|
19400 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 14.4
|
29600 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 12.2
|
45700 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 17.4
|
6000 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 20.5
|
5810 nanomole (nmol) * hours (h) /Liter (L)
Geometric Coefficient of Variation 20.5
|
—
|
SECONDARY outcome
Timeframe: Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects from the treated set (TS) who provided data for at least 1 PK endpoint, who were not excluded due to a protocol violation relevant to the evaluation of PK, and who were not excluded due to PK non-evaluability.
Maximum measured concentration of BI 764122 in plasma (Cmax).
Outcome measures
| Measure |
Placebo
n=6 Participants
placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
4 mg BI 764122
n=6 Participants
4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
12 mg BI 764122
n=6 Participants
1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
25 mg BI 764122
n=6 Participants
2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122
n=6 Participants
5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
100 mg BI 764122
n=6 Participants
1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
200 mg BI 764122
n=6 Participants
2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
300 mg BI 764122
n=6 Participants
3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
400 mg BI 764122
n=12 Participants
4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122 Fasted
n=12 Participants
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 hours. Food effect (FE) part.
|
50 mg BI 764122 Fed
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 764122 in Plasma (Cmax)
|
154 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 22.9
|
565 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 16.7
|
1280 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 35.3
|
2550 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 24.9
|
4410 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 45.6
|
8090 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 19.3
|
13300 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 48.4
|
18600 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 21.1
|
2610 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 46.3
|
1510 nanomle (nmol)/ Liter (L)
Geometric Coefficient of Variation 35.3
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
4 mg BI 764122
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
12 mg BI 764122
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 mg BI 764122
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 mg BI 764122
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 mg BI 764122
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
200 mg BI 764122
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 mg BI 764122
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
400 mg BI 764122
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 mg BI 764122 Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg BI 764122 Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
4 mg BI 764122
n=6 participants at risk
4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
|
12 mg BI 764122
n=6 participants at risk
1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
25 mg BI 764122
n=6 participants at risk
2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122
n=6 participants at risk
5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
100 mg BI 764122
n=6 participants at risk
1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
200 mg BI 764122
n=6 participants at risk
2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
300 mg BI 764122
n=6 participants at risk
3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
400 mg BI 764122
n=6 participants at risk
4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
|
50 mg BI 764122 Fasted
n=12 participants at risk
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 hours. Food effect (FE) part.
|
50 mg BI 764122 Fed
n=12 participants at risk
5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
6.2%
1/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
16.7%
1/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
8.3%
1/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.2%
1/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/6 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.
|
0.00%
0/12 • From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study 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 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