Trial Outcomes & Findings for A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink. (NCT NCT04194645)
NCT ID: NCT04194645
Last Updated: 2024-03-26
Results Overview
For assessment of safety and tolerability of BI 474121 the percentage of participants with drug-related adverse events (AE) was calculated. All AEs occurring between first drug intake till 7 days after last drug intake were assigned to the randomised treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
From drug administration until 7 days after drug administration, 7 days.
Results posted on
2024-03-26
Participant Flow
This was a two part trial in healthy male subjects: A single-blind, randomized, placebo-controlled single rising dose (SRD) scheme of BI 474121 (=SRD part); An open-label, randomized, 6-sequence cross-over to assess bioavailability (BA) of BI 474121 as oral solution (fasted state), tablet (fasted state) and tablet (fed state) (=BA part).
All subjects were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
A single dose of 1 mg BI 474121 was solved in 2mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
BA: BI 474121 10 mg as: OS Fasted (Reference (R)) / T Fasted (T2) / T Fed (T1)
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (Reference (R)), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (Test 2 (T2)) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (Test 1 (T1)). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10 mg as: R / T1 / T2
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg as: T2 / R / T1
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg as: T2 / T1 / R
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as oral solution solved in 20 mL water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg: T1 / R / T2
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg: T1 / T2 / R
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2) and in period 3 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (SRD and BA Part)
STARTED
|
4
|
9
|
6
|
6
|
6
|
6
|
6
|
5
|
6
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 1 (SRD and BA Part)
COMPLETED
|
4
|
9
|
6
|
6
|
6
|
6
|
6
|
5
|
6
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 1 (SRD and BA Part)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash-out Period 1 (BA Part Only)
STARTED
|
4
|
9
|
6
|
6
|
6
|
6
|
6
|
5
|
6
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Wash-out Period 1 (BA Part Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Wash-out Period 1 (BA Part Only)
NOT COMPLETED
|
4
|
9
|
6
|
6
|
6
|
6
|
6
|
5
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (BA Part Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 2 (BA Part Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 2 (BA Part Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash-out Period 2 (BA Part Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Wash-out Period 2 (BA Part Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Wash-out Period 2 (BA Part Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (BA Part Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 3 (BA Part Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 3 (BA Part Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
A single dose of 1 mg BI 474121 was solved in 2mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
BA: BI 474121 10 mg as: OS Fasted (Reference (R)) / T Fasted (T2) / T Fed (T1)
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (Reference (R)), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (Test 2 (T2)) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (Test 1 (T1)). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10 mg as: R / T1 / T2
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg as: T2 / R / T1
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg as: T2 / T1 / R
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as oral solution solved in 20 mL water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg: T1 / R / T2
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg: T1 / T2 / R
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2) and in period 3 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Wash-out Period 2 (BA Part Only)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.
Baseline characteristics by cohort
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=4 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=9 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=6 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
n=6 Participants
A single dose of 1 mg BI 474121 was solved in 2mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
n=6 Participants
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
n=6 Participants
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
n=6 Participants
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
n=5 Participants
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
n=6 Participants
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
BA: BI 474121 10 mg as: OS Fasted (Reference (R)) / T Fasted (T2) / T Fed (T1)
n=2 Participants
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (Reference (R)), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (Test 2 (T2)) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (Test 1 (T1)). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10 mg as: R / T1 / T2
n=2 Participants
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg as: T2 / R / T1
n=2 Participants
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg as: T2 / T1 / R
n=2 Participants
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as oral solution solved in 20 mL water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg: T1 / R / T2
n=2 Participants
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
|
BA: BI 474121 10mg: T1 / T2 / R
n=2 Participants
Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2) and in period 3 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
28.9 Years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
35.2 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
35.0 Years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
31.0 Years
STANDARD_DEVIATION 6.3 • n=21 Participants
|
32.0 Years
STANDARD_DEVIATION 7.5 • n=10 Participants
|
30.5 Years
STANDARD_DEVIATION 6.9 • n=115 Participants
|
35.8 Years
STANDARD_DEVIATION 6.5 • n=24 Participants
|
32.5 Years
STANDARD_DEVIATION 5.4 • n=42 Participants
|
29.0 Years
STANDARD_DEVIATION 5.7 • n=42 Participants
|
30.5 Years
STANDARD_DEVIATION 0.7 • n=42 Participants
|
34.5 Years
STANDARD_DEVIATION 10.6 • n=42 Participants
|
36.0 Years
STANDARD_DEVIATION 12.7 • n=36 Participants
|
31.0 Years
STANDARD_DEVIATION 1.4 • n=36 Participants
|
34.0 Years
STANDARD_DEVIATION 9.9 • n=24 Participants
|
32.4 Years
STANDARD_DEVIATION 6.4 • n=135 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
66 Participants
n=135 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
66 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
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
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 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
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
65 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: From drug administration until 7 days after drug administration, 7 days.Population: Treated set (TS) The TS included all participants who were randomized and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the participant received. The TS was used for safety analyses.
For assessment of safety and tolerability of BI 474121 the percentage of participants with drug-related adverse events (AE) was calculated. All AEs occurring between first drug intake till 7 days after last drug intake were assigned to the randomised treatment.
Outcome measures
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=4 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=9 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=6 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
n=6 Participants
A single dose of 1 mg BI 474121 was solved in 2 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
n=6 Participants
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
n=6 Participants
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
n=6 Participants
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
n=5 Participants
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
n=6 Participants
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
|---|---|---|---|---|---|---|---|---|---|
|
Single Rising Dose (SRD): Percentage of Subjects With Drug-related Adverse Events.
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
33.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all participants in the TS who provided at least 1 primary or secondary pharmacokinetic (PK) endpoint that were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was analyzed after single dose administration of BI 474121 as: an oral solution in fasted conditions (reference treatment), an uncoated tablet in fed conditions (treatment 1) and an uncoated tablet in fasted conditions (treatment 2). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Outcome measures
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=12 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=12 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=11 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
A single dose of 1 mg BI 474121 was solved in 2 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
|---|---|---|---|---|---|---|---|---|---|
|
Bioavailability (BA): Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz).
|
1180 Hour times nanomole per litre
Geometric Coefficient of Variation 42.6
|
1150 Hour times nanomole per litre
Geometric Coefficient of Variation 51.0
|
1300 Hour times nanomole per litre
Geometric Coefficient of Variation 37.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all participants in the TS who provided at least 1 primary or secondary pharmacokinetic (PK) endpoint that were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.
Maximum measured concentration of of BI 474121 in plasma (Cmax). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Outcome measures
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=12 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=12 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=11 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
A single dose of 1 mg BI 474121 was solved in 2 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
|---|---|---|---|---|---|---|---|---|---|
|
BA: Maximum Measured Concentration of BI 474121 in Plasma (Cmax )
|
165 Nanomole per litre
Geometric Coefficient of Variation 39.6
|
79.4 Nanomole per litre
Geometric Coefficient of Variation 39.0
|
95.3 Nanomole per litre
Geometric Coefficient of Variation 22.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS) The PKS included all participants in the TS who provided at least 1 primary or secondary pharmacokinetic (PK) endpoint that were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was analyzed after single dose administration of BI 474121. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Outcome measures
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=6 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=6 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=6 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
n=6 Participants
A single dose of 1 mg BI 474121 was solved in 2 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
n=6 Participants
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
n=5 Participants
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
n=6 Participants
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
|---|---|---|---|---|---|---|---|---|---|
|
SRD: Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz).
|
31.3 Hour times nanomole per litre
Geometric Coefficient of Variation 17.0
|
115 Hour times nanomole per litre
Geometric Coefficient of Variation 17.1
|
314 Hour times nanomole per litre
Geometric Coefficient of Variation 22.9
|
599 Hour times nanomole per litre
Geometric Coefficient of Variation 33.4
|
1130 Hour times nanomole per litre
Geometric Coefficient of Variation 31.0
|
2410 Hour times nanomole per litre
Geometric Coefficient of Variation 31.4
|
5130 Hour times nanomole per litre
Geometric Coefficient of Variation 30.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS) The PKS included all participants in the TS who provided at least 1 primary or secondary pharmacokinetic (PK) endpoint that were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.
Maximum measured concentration of of BI 474121 in plasma (Cmax). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Outcome measures
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=6 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=6 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=6 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
n=6 Participants
A single dose of 1 mg BI 474121 was solved in 2 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
n=6 Participants
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
n=5 Participants
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
n=6 Participants
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
|---|---|---|---|---|---|---|---|---|---|
|
SRD: Maximum Measured Concentration of of BI 474121 in Plasma (Cmax).
|
5.40 Nanomole per litre
Geometric Coefficient of Variation 26.3
|
19.4 Nanomole per litre
Geometric Coefficient of Variation 16.9
|
24.8 Nanomole per litre
Geometric Coefficient of Variation 12.6
|
44.3 Nanomole per litre
Geometric Coefficient of Variation 7.19
|
77.8 Nanomole per litre
Geometric Coefficient of Variation 29.4
|
189 Nanomole per litre
Geometric Coefficient of Variation 40.0
|
298 Nanomole per litre
Geometric Coefficient of Variation 29.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all participants in the TS who provided at least 1 primary or secondary pharmacokinetic (PK) endpoint that were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Outcome measures
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=12 Participants
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=12 Participants
This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=11 Participants
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
A single dose of 1 mg BI 474121 was solved in 2 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
|---|---|---|---|---|---|---|---|---|---|
|
BA: Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
|
1210 Hour times nanomole per litre
Geometric Coefficient of Variation 45.0
|
1190 Hour times nanomole per litre
Geometric Coefficient of Variation 53.6
|
1340 Hour times nanomole per litre
Geometric Coefficient of Variation 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SRD: Placebo Matching BI 474121 Oral Solution (OS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRD: Placebo Matching BI 474121 Tablet (T)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SRD: 0.25 Milligram (mg) BI 474121 - OS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRD: 1 mg BI 474121 - OS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRD: 2.5 mg BI 474121 - T
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SRD: 5 mg BI 474121 - T
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRD: 10 mg BI 474121 - T
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRD: 20 mg BI 474121 - T
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRD: 40 mg BI 474121 - T
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R))
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2))
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1))
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SRD: Placebo Matching BI 474121 Oral Solution (OS)
n=4 participants at risk
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
|
SRD: Placebo Matching BI 474121 Tablet (T)
n=9 participants at risk
This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
|
SRD: 0.25 Milligram (mg) BI 474121 - OS
n=6 participants at risk
A single dose of 0.25 mg BI 474121 was solved in 0.5 mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 1 mg BI 474121 - OS
n=6 participants at risk
A single dose of 1 mg BI 474121 was solved in 2mL water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 2.5 mg BI 474121 - T
n=6 participants at risk
A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 5 mg BI 474121 - T
n=6 participants at risk
A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 10 mg BI 474121 - T
n=6 participants at risk
A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 20 mg BI 474121 - T
n=5 participants at risk
A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
SRD: 40 mg BI 474121 - T
n=6 participants at risk
A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
|
BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R))
n=12 participants at risk
One single dose of 10 mg BI 474121 was administered as oral solution solved in 20 milliliter (mL) of water with 240 mL of water after an overnight fast.
|
BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2))
n=12 participants at risk
One single dose of 10 mg BI 474121 was administered as uncoated tablet with 240 mL of water after an overnight fast.
|
BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1))
n=11 participants at risk
One single dose of 10 mg BI 474121 was administered as uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
11.1%
1/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
11.1%
1/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
General disorders
Fatigue
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
11.1%
1/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
11.1%
1/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
8.3%
1/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
8.3%
1/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
9.1%
1/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
22.2%
2/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
33.3%
2/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
20.0%
1/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
2/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
2/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
9.1%
1/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/4 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/9 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
16.7%
1/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/5 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/6 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/12 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
0.00%
0/11 • SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).
|
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