Trial Outcomes & Findings for A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body (NCT NCT05879991)

Results Overview

Mass balance and total recovery of \[14C\]-radioactivity: fraction excreted in urine and faeces given as percentage of the administered oral dose of zongertinib (assessed by \[14C\]zongertinib-equivalent\[EQ\]) over the time interval from 0 to the last quantifiable time point (feurine, 0-tz; fefaeces, 0-tz) is reported. Timeframe (continued): after 336 h, if warranted, 24 h collections were to be performed every 7 days on days 21, 28, 35, and 42. Sampling was stopped when the release criteria for radioactivity recovery were met (earliest stopping on Day 15).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Within 18 h (urine) or 48 h (faeces) before drug intake; at 0-4, 4-8, 8-12, 12-24 (urine); and at 24 h sampling intervals until 336 h after drug intake (both). Both: after 336 h, every 7 days, up to day 42. Continues in description.

Results posted on

2025-10-06

Participant Flow

Part A was an open-label, single-arm, single-dose part to investigate the pharmacokinetics of zongertinib and \[14C\]-radioactivity following one oral dose of zongertinib (C-14) containing a radioactive dose of approximately 3.7 Megabecquerel (MBq). Part B was an open-label, single-arm, single-period part to compare zongertinib administered orally to the intravenous infusion 2 hours later of zongertinib (C-14) solution (radioactive dose was approximately 0.03 MBq).

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a 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

Participant milestones
Measure	Part A - Zongertinib (C-14) (T1) Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).	Part B - Zongertinib (T2), Then Zongertinib (C-14) (R) Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 \[T2\]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment \[R\]) via intravenous infusion. The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq.
Overall Study STARTED	8	7
Overall Study Treated	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - Zongertinib (C-14) (T1) n=8 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).	Part B - Zongertinib (T2), Then Zongertinib (C-14) (R) n=7 Participants Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 \[T2\]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment \[R\]) via intravenous infusion. The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq.	Total n=15 Participants Total of all reporting groups
Age, Continuous	27.8 Years STANDARD_DEVIATION 8.9 • n=5 Participants	29.3 Years STANDARD_DEVIATION 8.5 • n=7 Participants	28.5 Years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 18 h (urine) or 48 h (faeces) before drug intake; at 0-4, 4-8, 8-12, 12-24 (urine); and at 24 h sampling intervals until 336 h after drug intake (both). Both: after 336 h, every 7 days, up to day 42. Continues in description.

Population: Pharmacokinetic (PK) parameter analysis set (PKS) restricted to Part A included all part A subjects in the TS who provided 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.

Mass balance and total recovery of \[14C\]-radioactivity: fraction excreted in urine and faeces given as percentage of the administered oral dose of zongertinib (assessed by \[14C\]zongertinib-equivalent\[EQ\]) over the time interval from 0 to the last quantifiable time point (feurine, 0-tz; fefaeces, 0-tz) is reported. Timeframe (continued): after 336 h, if warranted, 24 h collections were to be performed every 7 days on days 21, 28, 35, and 42. Sampling was stopped when the release criteria for radioactivity recovery were met (earliest stopping on Day 15).

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=8 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part A - Fraction Excreted in Urine and Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe0-tz) feurine, 0-tz	1.30 Percentage of the administered dose Geometric Coefficient of Variation 16.8
Part A - Fraction Excreted in Urine and Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe0-tz) fefaeces, 0-tz	92.5 Percentage of the administered dose Geometric Coefficient of Variation 3.66
Part A - Fraction Excreted in Urine and Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe0-tz) feurine + fefaeces, 0-tz	93.8 Percentage of the administered dose Geometric Coefficient of Variation 3.62

PRIMARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration.

Population: PKS restricted to Part B included all part B subjects in the TS who provided 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.

The dose-normalised area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞,norm) after oral administration of zongertinib, and after intravenous administration of \[14C\]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=7 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞,Norm) zongertinib	223.39 hour*millimole/Liter/kilogram Standard Error NA Adjusted geometric standard error = 1.07
Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞,Norm) [14C]zongertinib	293.26 hour*millimole/Liter/kilogram Standard Error NA Adjusted geometric standard error = 1.07

SECONDARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration.

Population: PKS restricted to Part A included all part A subjects in the TS who provided 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 of zongertinib in plasma (Cmax) is reported.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=8 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part A - Maximum Measured Concentration of Zongertinib in Plasma (Cmax)	1160 nanomole/Liter Geometric Coefficient of Variation 17.2

SECONDARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration.

Population: PKS restricted to Part A included all part A subjects in the TS who provided 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 of \[14C\]-radioactivity (assessed by \[14C\]zongertinib-EQ) in plasma (Cmax) is reported.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=8 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part A - Maximum Measured Concentration of [14C]-Radioactivity (Assessed by [14C]Zongertinib-EQ) in Plasma (Cmax)	1450 nanomole/Liter Geometric Coefficient of Variation 18.8

SECONDARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration.

Population: PKS restricted to Part A included all part A subjects in the TS who provided 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.

Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) is reported.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=8 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part A - Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)	14100 hour*nanomole/Liter Geometric Coefficient of Variation 14.0

SECONDARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration.

Population: PKS restricted to Part A included all part A subjects in the TS who provided 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.

Area under the concentration-time curve of \[14C\]-radioactivity (assessed by \[14C\]zongertinib-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) is reported.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=8 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part A - Area Under the Concentration-time Curve of [14C]-Radioactivity (Assessed by [14C]Zongertinib-EQ) in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)	23700 hour*nanomole/Liter Geometric Coefficient of Variation 17.3

SECONDARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration.

Population: PKS restricted to Part B included all part B subjects in the TS who provided 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.

The dose-normalised maximum measured concentration in plasma (Cmax,norm) after oral administration of zongertinib, and after intravenous administration of \[14C\]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=7 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part B - Dose-normalised Maximum Measured Concentration in Plasma (Cmax,Norm) zongertinib	16.57 picomole/Liter/microgram Standard Error NA Adjusted geometric standard error = 1.10
Part B - Dose-normalised Maximum Measured Concentration in Plasma (Cmax,Norm) [14C]zongertinib	63.50 picomole/Liter/microgram Standard Error NA Adjusted geometric standard error = 1.10

SECONDARY outcome

Timeframe: Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration.

Population: PKS restricted to Part B included all part B subjects in the TS who provided 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.

The dose-normalised area under the concentration-time curve in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz,norm) after oral administration of zongertinib, and after intravenous administration of \[14C\]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Outcome measures

Outcome measures
Measure	Part A - Zongertinib (C-14) (T1) n=7 Participants Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz,Norm) [14C]zongertinib	285.38 hour*millimole/Liter/kilogram Standard Error NA Adjusted geometric standard error = 1.07
Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz,Norm) zongertinib	219.72 hour*millimole/Liter/kilogram Standard Error NA Adjusted geometric standard error = 1.07

Adverse Events

Part A - Zongertinib (C-14) (T1)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part B - Zongertinib (T2), Then Zongertinib (C-14) (R)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A - Zongertinib (C-14) (T1) n=8 participants at risk Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).	Part B - Zongertinib (T2), Then Zongertinib (C-14) (R) n=7 participants at risk Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 \[T2\]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment \[R\]) via intravenous infusion. The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq.
Infections and infestations Impetigo	50.0% 4/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Infections and infestations Tonsillitis	25.0% 2/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Infections and infestations Pharyngotonsillitis	12.5% 1/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Gastrointestinal disorders Diarrhoea	37.5% 3/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	14.3% 1/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Gastrointestinal disorders Abdominal discomfort	12.5% 1/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Nervous system disorders Headache	37.5% 3/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
General disorders Catheter site bruise	0.00% 0/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	14.3% 1/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
General disorders Catheter site haematoma	12.5% 1/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	0.00% 0/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.	14.3% 1/7 • From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks. Treated set (TS) included all subjects who were treated with at least one dose of trial drug.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

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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