Trial Outcomes & Findings for Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects (NCT NCT03123185)
NCT ID: NCT03123185
Last Updated: 2022-07-06
Results Overview
Number of participants with drug-related adverse events (AEs) is presented for SRD part.Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
91 participants
Primary outcome timeframe
From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).
Results posted on
2022-07-06
Participant Flow
This was a study in healthy men to test how different doses of BI 705564 are taken up in the body and whether taking BI 705564 with food makes a difference. The single rising dose (SRD) parts under fasting and fed conditions were designed as partially randomised within dose groups, placebo-controlled, single-blind, parallel-group design. The food effect (FE) part was designed as open-label, randomised, single-dose, two-period, two-sequence crossover design.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met. For the food effect part: Single dose for each treatment (2 single doses in total) were separated by a washout period of at least 10 days
Participant milestones
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
BI 705564 10 mg Fasted/ BI 705564 10 mg Fed (FE Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after an overnight fast of at least 10 h in period 1 (fast condition), with 240 milliliters (mL) of water.
Followed by single dose of 1x10 mg (10 mg) BI 705564 after a high-fat, high-calorie meal in period 2 (fed condition). Both treatments were separated by a washout period of at least 10 days.
|
BI 705564 10 mg Fed/BI 705564 10 mg Fasted (FE Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after a high-fat, high-calorie meal in period 1 (fed condition), with 240 milliliters (mL) of water.
Followed by single dose of 1x10 mg (10 mg) BI 705564 after an overnight fast of at least 10 h in period 2 (fast condition). Both treatments were separated by a washout period of at least 10 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
6
|
5
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
8
|
6
|
5
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
BI 705564 10 mg Fasted/ BI 705564 10 mg Fed (FE Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after an overnight fast of at least 10 h in period 1 (fast condition), with 240 milliliters (mL) of water.
Followed by single dose of 1x10 mg (10 mg) BI 705564 after a high-fat, high-calorie meal in period 2 (fed condition). Both treatments were separated by a washout period of at least 10 days.
|
BI 705564 10 mg Fed/BI 705564 10 mg Fasted (FE Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after a high-fat, high-calorie meal in period 1 (fed condition), with 240 milliliters (mL) of water.
Followed by single dose of 1x10 mg (10 mg) BI 705564 after an overnight fast of at least 10 h in period 2 (fast condition). Both treatments were separated by a washout period of at least 10 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
n=12 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=8 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
n=5 Participants
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
BI 705564 10 mg Fasted/ BI 705564 10 mg Fed (FE Part)
n=6 Participants
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after an overnight fast of at least 10 h in period 1 (fast condition), with 240 milliliters (mL) of water.
Followed by single dose of 1x10 mg (10 mg) BI 705564 after a high-fat, high-calorie meal in period 2 (fed condition). Both treatments were separated by a washout period of at least 10 days.
|
BI 705564 10 mg Fed/BI 705564 10 mg Fasted (FE Part)
n=6 Participants
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after a high-fat, high-calorie meal in period 1 (fed condition), with 240 milliliters (mL) of water.
Followed by single dose of 1x10 mg (10 mg) BI 705564 after an overnight fast of at least 10 h in period 2 (fast condition). Both treatments were separated by a washout period of at least 10 days.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
39.1 Years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
36.0 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
29.6 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
32.5 Years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
33.3 Years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
36.8 Years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
35.3 Years
STANDARD_DEVIATION 8.6 • n=24 Participants
|
37.7 Years
STANDARD_DEVIATION 8.8 • n=42 Participants
|
30.2 Years
STANDARD_DEVIATION 6.7 • n=42 Participants
|
33.8 Years
STANDARD_DEVIATION 7.9 • n=42 Participants
|
38.7 Years
STANDARD_DEVIATION 7.6 • n=42 Participants
|
29.3 Years
STANDARD_DEVIATION 10.2 • n=36 Participants
|
34.2 Years
STANDARD_DEVIATION 12.2 • n=36 Participants
|
34.5 Years
STANDARD_DEVIATION 8.5 • 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
91 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
91 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).Population: Treated set (TS): TS included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of the investigational treatment.
Number of participants with drug-related adverse events (AEs) is presented for SRD part.Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.
Outcome measures
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
n=12 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=8 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
n=20 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
n=5 Participants
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
n=35 Participants
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
n=6 Participants
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
n=24 Participants
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
n=59 Participants
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Drug-related Adverse Events (AEs)
|
3 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability.
AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented.
Outcome measures
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
n=11 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=12 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part)
|
NA nanomole*hour/litre [nmol*h/L]
Standard Error NA
Least squares mean is actually adjusted geometric mean (gMean). Adjusted geometric mean (gMean)= 46.068.
Standard error is actually geometric standard error. Geometric standard error ="1.099"
|
NA nanomole*hour/litre [nmol*h/L]
Standard Error NA
Least squares mean is actually adjusted geometric mean (gMean). Adjusted geometric mean (gMean)= 29.044.
Standard error is actually geometric standard error. Geometric standard error =1.095
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PRIMARY outcome
Timeframe: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability.
Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part.
Outcome measures
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
n=11 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=12 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part)
|
NA Nanomole/litre [nmol/L]
Standard Error NA
Least squares mean is actually adjusted geometric mean (gMean). Adjusted geometric mean (gMean)= 13.109 Standard error is actually geometric standard error. Geometric standard error =1.110
|
NA Nanomole/litre [nmol/L]
Standard Error NA
Least squares mean is actually adjusted geometric mean (gMean). Adjusted geometric mean (gMean)= 6.751.
Standard error is actually geometric standard error. Geometric standard error =1.105
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SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability.
Cmax, maximum measured concentration of BI 705564 in plasma is presented for SRD part.
Outcome measures
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=5 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
n=6 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
n=6 Participants
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part)
|
1.66 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 26.9
|
7.51 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 34.9
|
4.94 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 25.9
|
12.9 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 55.5
|
14.5 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 40.7
|
16.5 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 29.3
|
23.9 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 17.0
|
41.2 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 36.0
|
58.3 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 12.1
|
122.0 Nanomole/litre [nmol/L]
Geometric Coefficient of Variation 58.0
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SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability.
AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity is presented for SRD part.
Outcome measures
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=5 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
n=6 Participants
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
n=5 Participants
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
n=5 Participants
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
n=6 Participants
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
n=4 Participants
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
n=5 Participants
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
n=6 Participants
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part)
|
NA nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation NA
NA= Not calculated because plasma concentrations were below lower limit of quantification (BLQ)
|
NA nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation NA
NA= Not calculated because plasma concentrations were below lower limit of quantification (BLQ)
|
NA nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation NA
NA= Not calculated because plasma concentrations were below lower limit of quantification (BLQ)
|
54.0 nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation 29.7
|
74.2 nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation 37.4
|
98.1 nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation 43.4
|
NA nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation NA
NA= Not calculated because plasma concentrations were below lower limit of quantification (BLQ)
|
185.0 nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation 35.5
|
330.0 nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation 31.2
|
481.0 nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation 48.2
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SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.Population: PKS: Only participants with evaluable results for this PK parameter are reported.
AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity.
Outcome measures
| Measure |
Placebo Matching BI 705564 Fasted (SRD Part)
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=2 Participants
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
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10 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part)
|
—
|
NA nanomole*hour/litre [nmol*h/L]
Geometric Coefficient of Variation NA
Geometric mean and Geometric Coefficient of Variation could not be calculated because of the limited sample size.
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Adverse Events
Placebo Matching BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Matching BI 705564 Fed (SRD Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Matching BI 705564 Total
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
1 Milligram (mg) BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3 mg BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
20 mg BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
40 mg BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
80 mg BI 705564 Fasted (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total BI 705564 Fast (SRD Part)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
20 mg BI 705564 Fed (SRD Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
40 mg BI 705564 Fed (SRD Part)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
80 mg BI 705564 Fed (SRD Part)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
160 mg BI 705564 Fed (SRD Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Total BI 705564 Fed (SRD Part)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Total BI 705564 (SRD Part)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
10 mg BI 705564 Fast (FE Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 mg BI 705564 Fed (FE Part)
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 Matching BI 705564 Fasted (SRD Part)
n=12 participants at risk
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
|
Placebo Matching BI 705564 Fed (SRD Part)
n=8 participants at risk
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Placebo Matching BI 705564 Total
n=20 participants at risk
Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
1 Milligram (mg) BI 705564 Fasted (SRD Part)
n=6 participants at risk
Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
3 mg BI 705564 Fasted (SRD Part)
n=5 participants at risk
Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fasted (SRD Part)
n=6 participants at risk
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fasted (SRD Part)
n=6 participants at risk
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
40 mg BI 705564 Fasted (SRD Part)
n=6 participants at risk
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
80 mg BI 705564 Fasted (SRD Part)
n=6 participants at risk
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 705564 Fast (SRD Part)
n=35 participants at risk
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
20 mg BI 705564 Fed (SRD Part)
n=6 participants at risk
Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
40 mg BI 705564 Fed (SRD Part)
n=6 participants at risk
Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
80 mg BI 705564 Fed (SRD Part)
n=6 participants at risk
Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
160 mg BI 705564 Fed (SRD Part)
n=6 participants at risk
Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
Total BI 705564 Fed (SRD Part)
n=24 participants at risk
Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal
|
Total BI 705564 (SRD Part)
n=59 participants at risk
Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition.
|
10 mg BI 705564 Fast (FE Part)
n=12 participants at risk
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.
|
10 mg BI 705564 Fed (FE Part)
n=11 participants at risk
Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
9.1%
1/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
9.1%
1/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
3.4%
2/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
9.1%
1/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
General disorders
Chest pain
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
9.1%
1/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
8.3%
1/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
20.0%
1/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
9.1%
1/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
1/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
20.0%
4/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
33.3%
2/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
14.3%
5/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
12.5%
3/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
13.6%
8/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
3.4%
2/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
8.3%
1/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
9.1%
1/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Vascular disorders
Haematoma
|
8.3%
1/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.7%
2/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
4.2%
1/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.1%
3/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Vascular disorders
Hot flush
|
8.3%
1/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
5.0%
1/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/8 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/20 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/5 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
16.7%
1/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
2.9%
1/35 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/6 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/24 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
1.7%
1/59 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/12 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
0.00%
0/11 • From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
|
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