Trial Outcomes & Findings for A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid (NCT NCT04672954)
NCT ID: NCT04672954
Last Updated: 2024-03-08
Results Overview
Maximum exposure-related change from baseline (calculated as ratio) of cyclic guanosine monophosphate (cGMP) in Cerebrospinal fluid (CSF). In subjects treated with BI 474121 this is the maximum cGMP value measured within 1 hour (h) prior and 4 h post BI 474121 Maximum measured concentration (Cmax) in CSF. For subjects treated with placebo, this is the maximum cGMP value measured within 1 h prior to and 4 h after the median BI 474121 tmax (time from (last) dosing to the maximum measured concentration of the analyte) in CSF of the BI 474121 treated subjects. Baseline cGMP concentration was calculated as the arithmetic mean of all pre-dose measurements above Lower limit of quantification (LLOQ) obtained in that subject. The maximum exposure-related change from baseline in cGMP in CSF was explored using an analysis of covariance (ANCOVA) model on the logarithmic scale. Maximum exposure related cGMP: Ratio \[maximum cGMP / baseline cGMP\].
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Within approximately 2, 1, and 0.17 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 and 24 hours following drug administration.
Results posted on
2024-03-08
Participant Flow
This study consisted of three parts, part 1: randomised, placebo-controlled, single-blind, part 2:non-randomised, open-label and part 3: randomised, open-label, with the aim of exploring the pharmacokinetics and pharmacodynamic effects of different single oral doses of BI 474121 in healthy male subjects
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=4 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=6 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
n=6 Participants
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 24.3 • n=99 Participants
|
27.5 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
22.0 years
STANDARD_DEVIATION 3.2 • n=206 Participants
|
38.3 years
STANDARD_DEVIATION 17.4 • n=7 Participants
|
23.2 years
STANDARD_DEVIATION 2.9 • n=31 Participants
|
30.5 years
STANDARD_DEVIATION 14.9 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
23 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Within approximately 2, 1, and 0.17 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 and 24 hours following drug administration.Population: Pharmacodynamic parameter analysis set (PDS): all evaluable subjects who were entered and treated with one dose of study drug and who provided at least one evaluable pre- and post-dose measure for a pharmacodynamic endpoint.
Maximum exposure-related change from baseline (calculated as ratio) of cyclic guanosine monophosphate (cGMP) in Cerebrospinal fluid (CSF). In subjects treated with BI 474121 this is the maximum cGMP value measured within 1 hour (h) prior and 4 h post BI 474121 Maximum measured concentration (Cmax) in CSF. For subjects treated with placebo, this is the maximum cGMP value measured within 1 h prior to and 4 h after the median BI 474121 tmax (time from (last) dosing to the maximum measured concentration of the analyte) in CSF of the BI 474121 treated subjects. Baseline cGMP concentration was calculated as the arithmetic mean of all pre-dose measurements above Lower limit of quantification (LLOQ) obtained in that subject. The maximum exposure-related change from baseline in cGMP in CSF was explored using an analysis of covariance (ANCOVA) model on the logarithmic scale. Maximum exposure related cGMP: Ratio \[maximum cGMP / baseline cGMP\].
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=4 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=6 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
n=5 Participants
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Maximum Exposure-related Change From Baseline (Calculated as Ratio) of Cyclic Guanosine Monophosphate (cGMP) in Cerebrospinal Fluid (CSF)
|
NA maximum change from baseline cGMP ratio
Standard Error NA
Geometric Mean is adjusted Geometric Mean = 1.26 Standard Error is Geometric standard error (gSE) = 1.24
|
NA maximum change from baseline cGMP ratio
Standard Error NA
Geometric Mean is adjusted Geometric Mean = 1.62 Standard Error is Geometric standard error (gSE) = 1.23
|
NA maximum change from baseline cGMP ratio
Standard Error NA
Geometric Mean is adjusted Geometric Mean = 2.09 Standard Error is Geometric standard error (gSE) = 1.23
|
NA maximum change from baseline cGMP ratio
Standard Error NA
Geometric Mean is adjusted Geometric Mean = 1.44 Standard Error is Geometric standard error (gSE) = 1.18
|
NA maximum change from baseline cGMP ratio
Standard Error NA
Geometric Mean is adjusted Geometric Mean = 2.20 Standard Error is Geometric standard error (gSE) = 1.20
|
PRIMARY outcome
Timeframe: Up to 72 hours, see endpoint description for detailed sampling scheme.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects who were entered and treated with one dose of study drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration (Cmax) ratio of BI 474121 in CSF compared to plasma. Mixed effects model: random effect 'subject nested within treatment', fixed effect, treatment, substance and their interaction' (for estimation of overall group effect the model was run without interaction term). Cmax was log transformed (natural logarithm) prior to fitting the model. Difference between expected means for log(CSF)- log(plasma) was estimated by difference in the corresponding least square means (point estimate) and two-sided 90% CI based on the t-distribution were computed. Quantities were back-transformed to the original scale to give an point estimator and interval estimate. Ratio = CSF (T) / plasma (R). Plasma: Within 3 hours (h) before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 34, 48 and 72 h following drug administration. CSF: Within approximately 2, 1, and 0.17 h before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 and 24 h following drug administration.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=6 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=5 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
n=19 Participants
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration (Cmax) Ratio of BI 474121 in Cerebrospinal Fluid (CSF) Compared to Plasma
|
9.49 Ratio [%] Cmax CSF (T) / Cmax Plasma (R)
Interval 8.27 to 10.89
|
7.88 Ratio [%] Cmax CSF (T) / Cmax Plasma (R)
Interval 6.86 to 9.04
|
9.89 Ratio [%] Cmax CSF (T) / Cmax Plasma (R)
Interval 8.84 to 11.07
|
8.42 Ratio [%] Cmax CSF (T) / Cmax Plasma (R)
Interval 7.45 to 9.53
|
8.96 Ratio [%] Cmax CSF (T) / Cmax Plasma (R)
Interval 8.37 to 9.59
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 34, 48 and 72 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects who were entered and treated with one dose of study drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject will be included in the PKS, even if he/she contributes only one PK parameter value to the statistical assessment.
Maximum measured concentration (Cmax) of BI 474121 in plasma.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=6 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=5 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration (Cmax) of BI 474121 in Plasma
|
22.0 Nanomol/Liter
Geometric Coefficient of Variation 30.0
|
87.2 Nanomol/Liter
Geometric Coefficient of Variation 30.3
|
137 Nanomol/Liter
Geometric Coefficient of Variation 21.7
|
278 Nanomol/Liter
Geometric Coefficient of Variation 13.4
|
—
|
SECONDARY outcome
Timeframe: Within approximately 2, 1, and 0.17 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 and 24 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects who were entered and treated with one dose of study drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject will be included in the PKS, even if he/she contributes only one PK parameter value to the statistical assessment.
Maximum measured concentration (Cmax) of BI 474121 in Cerebrospinal fluid (CSF).
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=6 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=5 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration (Cmax) of BI 474121 in Cerebrospinal Fluid (CSF)
|
2.09 Nanomol/Liter
Geometric Coefficient of Variation 27.9
|
6.87 Nanomol/Liter
Geometric Coefficient of Variation 25.9
|
13.6 Nanomol/Liter
Geometric Coefficient of Variation 9.17
|
23.5 Nanomol/Liter
Geometric Coefficient of Variation 25.0
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 34, 48 and 72 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects who were entered and treated with one dose of study drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject will be included in the PKS, even if he/she contributes only one PK parameter value to the statistical assessment.
Time from dosing to maximum measured BI 474121 concentrations in plasma (tmax).
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=6 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=5 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Time From Dosing to Maximum Measured BI 474121 Concentrations in Plasma (Tmax)
|
4.00 hours
Interval 1.5 to 5.02
|
1.50 hours
Interval 1.0 to 3.0
|
2.01 hours
Interval 1.0 to 3.0
|
4.00 hours
Interval 1.5 to 5.08
|
—
|
SECONDARY outcome
Timeframe: Within approximately 2, 1, and 0.17 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 and 24 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects who were entered and treated with one dose of study drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject will be included in the PKS, even if he/she contributes only one PK parameter value to the statistical assessment.
Time from dosing to maximum measured BI 474121 concentrations in CSF (tmax).
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=6 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=5 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Time From Dosing to Maximum Measured BI 474121 Concentrations in CSF (Tmax)
|
2.03 hours
Interval 2.03 to 4.02
|
2.03 hours
Interval 1.02 to 3.02
|
3.02 hours
Interval 2.03 to 3.07
|
4.03 hours
Interval 2.03 to 5.12
|
—
|
SECONDARY outcome
Timeframe: Within approximately 2, 1, and 0.17 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 and 24 hours following drug administration.Population: Pharmacodynamic parameter analysis set (PDS): This set includes all evaluable subjects who provide at least one evaluable pre- and post-dose measure for a PD endpoint.
Maximum measured exposure-related cGMP concentration in CSF. In subjects treated with BI 474121 this is the maximum cGMP value measured within 1 hour (h) prior and 4 h post BI 474121 Maximum measured concentration (Cmax) in CSF. For subjects treated with placebo, this is the maximum cGMP value measured within 1 h prior to and 4 h after the median BI 474121 tmax (time from (last) dosing to the maximum measured concentration of the analyte) in CSF of the BI 474121 treated subjects.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 Participants
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=4 Participants
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=6 Participants
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
n=5 Participants
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
Maximum Measured Exposure-related cGMP Concentration in Cerebrospinal Fluid (CSF)
|
7.51 Nanomol/Liter
Geometric Coefficient of Variation 40.0
|
9.54 Nanomol/Liter
Geometric Coefficient of Variation 32.5
|
10.7 Nanomol/Liter
Geometric Coefficient of Variation 79.2
|
7.36 Nanomol/Liter
Geometric Coefficient of Variation 40.4
|
11.1 Nanomol/Liter
Geometric Coefficient of Variation 37.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2.5 Milligram (mg) BI 474121
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10 Milligram (mg) BI 474121
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
20 Milligram (mg) BI 474121
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
40 Milligram (mg) BI 474121
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Placebo matching to 10 mg BI 474121 administered as uncoated tablets with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1: randomised, placebo-controlled, single-blind.
|
2.5 Milligram (mg) BI 474121
n=4 participants at risk
2.5 mg BI 474121 administered as uncoated tablets (1 x 2.5 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
10 Milligram (mg) BI 474121
n=4 participants at risk
10 mg BI 474121 administered as uncoated tablets (1 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 3 of the study: randomised, open-label.
|
20 Milligram (mg) BI 474121
n=6 participants at risk
20 mg BI 474121 administered as uncoated tablets (2 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 1 of the study: randomised, placebo-controlled, single-blind.
|
40 Milligram (mg) BI 474121
n=6 participants at risk
40 mg BI 474121 administered as uncoated tablets (4 x 10 mg) with 240 milliliter of water after subjects fasted overnight for at least 10 hours. This arm was part of Part 2 of the study: non-randomised, open-label.
|
|---|---|---|---|---|---|
|
General disorders
Feeling hot
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
General disorders
Hangover
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
General disorders
Puncture site pain
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
75.0%
3/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
100.0%
4/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
100.0%
4/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
83.3%
5/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
83.3%
5/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
50.0%
2/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
75.0%
3/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
50.0%
2/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
33.3%
2/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
33.3%
2/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
50.0%
2/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Nervous system disorders
Neuralgia
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
33.3%
2/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
50.0%
2/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
66.7%
4/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
50.0%
2/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
16.7%
1/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
33.3%
2/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
25.0%
1/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
50.0%
2/4 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
0.00%
0/6 • Adverse events: day of drug administration + 7 days, up to 7 days. All-cause mortality: day of drug administration till trial completion date, up to 14 days.
Treated set (TS): The treated set includes all entered subjects who were treated with one dose of study drug (i.e. verum or placebo).
|
Additional Information
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Email: [email protected]
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- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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