Trial Outcomes & Findings for A Study in Healthy Men to Test How BI 764198 is Processed in the Body (NCT NCT05863130)
NCT ID: NCT05863130
Last Updated: 2026-06-29
Results Overview
Urine: Within 2 hours before drug administration, and at 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. Feces: up to 48 hours (feces) before drug administration, and at 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. If warranted, further 24-hour collections at trial site were performed at 365-389, 533-557-, and 701-725-hours post-administration depending on participants fulfilling the radioactivity recovery criteria.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section.
Results posted on
2026-06-29
Participant Flow
This open-label, non randomised, single-dose, single-period, two-arm phase I trial investigates the mass balance, metabolism, and pharmacokinetics of a single dose of BI 764198 in healthy males. Study arm 1 uses a classical hADME approach, while study arm 2 uses a microtracer approach and is divided into two cohorts (2a and 2b). Participants were allocated in a 1:2 ratio based on availability.
An additional cohort (2b) was introduced due to errors in plasma samples from the first 8 participants in cohort 2a, preventing reliable metabolite profiling. Cohort 2b received the same treatment to enable proper profiling. The assessment schedule for cohort 2b was abbreviated, release criteria were not applied, and data from cohorts 2a and 2b were pooled for analysis. The sample size for the microtracer approach was doubled compared to the classical ADME approach.
Participant milestones
| Measure |
Cohort 1: Classical hADME
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
16
|
|
Overall Study
COMPLETED
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How BI 764198 is Processed in the Body
Baseline characteristics by cohort
| Measure |
Cohort 1: Classical hADME
n=8 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
n=16 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 11.5 • n=9 Participants
|
37.3 years
STANDARD_DEVIATION 16.5 • n=27 Participants
|
35.4 years
STANDARD_DEVIATION 15.0 • n=267 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section.Population: Pharmacokinetic (PK) Analysis Set (PKS): Participants in the treated set (TS) with at least one primary or secondary PK endpoint, excluding those with protocol deviations affecting PK evaluation or non-evaluable data. One participant in Cohort 1 did not collect all urine and feces samples, urine data for one participant in Cohort 2 were also excluded due to incomplete collection. As per protocol, only the initial 8 subjects in Cohort 2 (2a) were included in the primary endpoint.
Urine: Within 2 hours before drug administration, and at 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. Feces: up to 48 hours (feces) before drug administration, and at 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. If warranted, further 24-hour collections at trial site were performed at 365-389, 533-557-, and 701-725-hours post-administration depending on participants fulfilling the radioactivity recovery criteria.
Outcome measures
| Measure |
Cohort 1: Classical hADME
n=7 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
n=8 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces.
Urine
|
73.7 Percentage of dose excreted
Geometric Coefficient of Variation 6.23
|
73.2 Percentage of dose excreted
Geometric Coefficient of Variation 6.04
|
|
Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces.
Faeces
|
22.9 Percentage of dose excreted
Geometric Coefficient of Variation 10.7
|
22.4 Percentage of dose excreted
Geometric Coefficient of Variation 10.6
|
SECONDARY outcome
Timeframe: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of \[14C\]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form.
Outcome measures
| Measure |
Cohort 1: Classical hADME
n=8 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
n=16 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
AUC0-tz, Area Under the Concentration-time Curve of [14C]-BI 764198-EQ Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198.
|
27500 Hours * nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 11.1
|
37600 Hours * nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 24.4
|
SECONDARY outcome
Timeframe: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points.
Outcome measures
| Measure |
Cohort 1: Classical hADME
n=8 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
n=16 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
AUC0-tz, Area Under the Concentration-time Curve of BI 764198 Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198.
|
13200 Hours * nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 13.2
|
14500 Hours * nanomoles per liter (h*nmol/L)
Geometric Coefficient of Variation 24.6
|
SECONDARY outcome
Timeframe: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of \[14C\]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form. This standardization ensures that the data can be accurately compared to the unlabeled BI 764198.
Outcome measures
| Measure |
Cohort 1: Classical hADME
n=8 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
n=16 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Cmax, Maximum Measured Concentration of [14C]-BI 764198-EQ in Plasma After Single Oral Administration of [14C]BI 76418.
|
1740 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 20.7
|
1800 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 16.7
|
SECONDARY outcome
Timeframe: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points.
Outcome measures
| Measure |
Cohort 1: Classical hADME
n=8 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2: Microtracer hADME
n=16 Participants
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Cmax, Maximum Measured Concentration of BI 76418 in Plasma After Single Oral Administration of [14C]BI 76418.
|
1420 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 19.8
|
1450 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 23.7
|
Adverse Events
Cohort 1: Classical hADME
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2a: Microtracer hADME
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2b: Microtracer hADME
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Classical hADME
n=8 participants at risk
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2a: Microtracer hADME
n=8 participants at risk
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
Cohort 2b: Microtracer hADME
n=8 participants at risk
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
25.0%
2/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
2/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
25.0%
2/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
General disorders
Pain
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Erythema marginatum
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
1/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/8 • AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER