Trial Outcomes & Findings for This Study in Healthy Men Tests How the Body Takes up BI 1467335 (NCT NCT03483506)

NCT ID: NCT03483506

Last Updated: 2021-07-08

Results Overview

After the first dose: Area under the concentration-time curve of BI 1467335 over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 1467335 (after oral administration) and \[C-14\] BI 1467335 (after iv administration) on Day 1 is presented. Standard Error is actually a geometric standard Error in method of dispersion. Pharmacokinetic samples were collected on Day 1 for both groups.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: Within 2 hours (h) before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6 and 8 h after BI intake. Within 2h before and 1.083, 1.25, 1.417, 1.583, 1.75, 2, 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after [C-14] BI intake.
• Results posted on: 2021-07-08

Participant Flow

This was an open-label, non-randomized, single arm, multiple dose design trial in healthy male participants received unlabelled oral doses of BI 1467335 (Test product 1 (T1), film coated tablet) for 28 days and in addition microtracer-radiolabelled BI 1467335 as intravenous (iv) infusions on Days 1 and 28 (Test product 2 (T2)).

All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered to trial if any one of the specific entry criteria were not met.

Participant milestones

Measure	BI 1467335 All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg \[C-14\] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg \[C-14\] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This Study in Healthy Men Tests How the Body Takes up BI 1467335

Baseline characteristics by cohort

Measure	BI 1467335 n=12 Participants All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg \[C-14\] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg \[C-14\] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later.
Age, Continuous	37.3 Years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 hours (h) before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6 and 8 h after BI intake. Within 2h before and 1.083, 1.25, 1.417, 1.583, 1.75, 2, 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after [C-14] BI intake.

Population: Pharmacokinetic (PK) set (PKS): All subjects in the TS who provided at least one primary PK parameter not excluded due to a protocol violation relevant to the statistical evaluation of PK endpoints.

After the first dose: Area under the concentration-time curve of BI 1467335 over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 1467335 (after oral administration) and [C-14] BI 1467335 (after iv administration) on Day 1 is presented.

Standard Error is actually a geometric standard Error in method of dispersion. Pharmacokinetic samples were collected on Day 1 for both groups.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
After the First Dose: Area Under the Concentration-time Curve of BI 1467335 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) of BI 1467335 (After Oral Administration) and [C-14] BI 1467335 (After iv Administration) on Day 1	0.35 millimole * hour/ Liter/ kilogram Standard Error 1.25	4.16 millimole * hour/ Liter/ kilogram Standard Error 1.25

PRIMARY outcome

Timeframe: Within 2 hours (h) before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6 and 8 h after BI intake. Within 2h before and 1.083, 1.25, 1.417, 1.583, 1.75, 2, 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after [C-14] BI intake.

Population: PKS

After the first dose: maximum measured concentration of BI 1467335 in plasma (Cmax ) of BI 1467335 (after oral administration) and [C-14] BI 1467335 (after iv administration) on Day 1 is presented.

Pharmacokinetic samples were collected on Day 1 for both groups.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
After the First Dose: Maximum Measured Concentration of the BI 1467335 in Plasma (Cmax ) of BI 1467335 (After Oral Administration) and [C-14] BI 1467335 (After iv Administration) on Day 1	2.72 nanomole/Liter (nmol/L) Geometric Coefficient of Variation 105.0	0.152 nanomole/Liter (nmol/L) Geometric Coefficient of Variation 87.6

PRIMARY outcome

Timeframe: 5 min before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6, 8, 10, 12 and 24h after BI intake. Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI intake.

Population: PKS

After the multiple doses Area under the concentration-time curve of the BI 1467335 over the time interval from 0 extrapolated to 24 h after oral administration of BI 1467335 and after intravenous administration of [C-14] BI 1467335 on Day 28 (AUC 0-infinity, 28) is presented.

Standard Error is actually a geometric standard Error in method of dispersion. Pharmacokinetic samples were collected before and after dispense of study medication on Day 28 for both groups. Please refer to time frame for further details.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Area Under the Concentration-time Curve of BI 1467335 Over the Time Interval From 0 Extrapolated to Infinity After Oral Administration of BI 1467335 and After Intravenous Administration of [C-14] BI 1467335 on Day 28 (AUC 0-infinity, 28)	37.38 millimole*hour/ Liter/ kilogram Standard Error 1.24	60.16 millimole*hour/ Liter/ kilogram Standard Error 1.24

PRIMARY outcome

Timeframe: 5 min before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6, 8, 10, 12 and 24h after BI intake. Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI intake.

Population: PKS

After multiple doses: maximum measured concentration of the analyte in plasma of BI 1467335 after oral administration and [C-14] BI 1467335 after intravenous administration on Day 28 (Cmax, 28) is presented.

Pharmacokinetic samples were collected before and after dispense of study medication on Day 28 for both groups. Please refer to time frame for further details.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
After Multiple Doses: Maximum Measured Concentration of BI 1467335 in Plasma of BI 1467335 After Oral Administration and [C-14] BI 1467335 After Intravenous Administration on Day 28 (Cmax, 28)	92.5 nanomole/Liter (nmol/L) Geometric Coefficient of Variation 42.8	0.290 nanomole/Liter (nmol/L) Geometric Coefficient of Variation 19.5

SECONDARY outcome

Timeframe: Within 2 hours (h) before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6 and 8 h after BI intake. Within 2h before and 1.083, 1.25, 1.417, 1.583, 1.75, 2, 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after [C-14] BI intake.

Population: PKS

Time from dosing to the maximum measured concentration of BI 1467335 after oral administration of BI 1467335 and after intravenous administration of [C-14] BI 1467335 on Day 1 (tmax).

Pharmacokinetic samples were collected on Day 1 for both groups.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Time From Dosing to the Maximum Measured Concentration of BI 1467335 After Oral Administration of BI 1467335 and After Intravenous Administration of [C-14] BI 1467335 on Day 1 (Tmax)	1.08 Hours (h) Interval 0.75 to 1.09	0.250 Hours (h) Interval 0.0915 to 0.25

SECONDARY outcome

Timeframe: 5 min before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6, 8, 10, 12 and 24h after BI intake. Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI intake.

Population: PKS

Time from dosing to the maximum measured concentration of BI 1467335 after oral administration of BI 1467335 and after intravenous administration of [C-14] BI 1467335 on Day 28 (tmax,28).

Pharmacokinetic samples were collected before and after dispense of study medication on Day 28 for both groups. Please refer to time frame for further details.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Time From Dosing to the Maximum Measured Concentration of BI 1467335 After Oral Administration of BI 1467335 and After Intravenous Administration of [C-14] BI 1467335 on Day 28 (Tmax,28)	1.08 Hours (h) Interval 1.08 to 1.42	0.250 Hours (h) Interval 0.167 to 0.25

SECONDARY outcome

Timeframe: Within 2 hours (h) before and 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6 and 8 h after BI intake. Within 2h before and 1.083, 1.25, 1.417, 1.583, 1.75, 2, 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after [C-14] BI intake.

Population: PKS

Observed terminal half-life of BI 1467335 after oral administration of BI 1467335 and after intravenous administration of [C-14] BI 1467335 on Day 1 (t1/2).

Pharmacokinetic samples were collected on Day 1 for both groups.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv n=12 Participants Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Observed Terminal Half-life of BI 1467335 After Oral Administration of BI 1467335 and After Intravenous Administration of [C-14] BI 1467335 on Day 1 (t1/2)	0.751 Hours (h) Interval 0.614 to 0.905	0.341 Hours (h) Interval 0.256 to 0.78

SECONDARY outcome

Timeframe: Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI 1467335 intake on Day 28.

Population: PKS

Observed terminal half-life of the analyte [C-14] BI 1467335 after intravenous administration on Day 28 (t1/2,28).

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Observed Terminal Half-life of the Analyte [C-14] BI 1467335 After Intravenous Administration on Day 28 (t1/2,28)	2.43 Hours (h) Interval 1.43 to 3.79	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken 2 h pre-dose and at 1.083, 1.25, 1.417, 1.583, 1.75, 2 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after last drug administration on day 1 for [C-14] BI 1467335.

Population: PKS

Clearance of the analyte [C-14] BI 1467335 after intravenous administration on Day 1 (CL).

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Clearance of the Analyte [C-14] BI 1467335 After Intravenous Administration on Day 1 (CL)	14300.0 millilitre/minute (mL/min) Geometric Coefficient of Variation 87.2	—

SECONDARY outcome

Timeframe: Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI 1467335 intake on Day 28.

Population: PKS

Clearance of the analyte [C-14] BI 1467335 after intravenous administration on Day 28 (CL28).

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Clearance of the Analyte [C-14] BI 1467335 After Intravenous Administration on Day 28 (CL28)	988 millilitre/minute (mL/min) Geometric Coefficient of Variation 66	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken 2 h pre-dose and at 1.083, 1.25, 1.417, 1.583, 1.75, 2 2.25, 2.75, 3.25, 3.75, 4.25, 4.75, 5.25, 6.25, 7.25, 8.25, 9.25 and 13 h after last drug administration on day 1 for [C-14] BI 1467335.

Population: PKS

Volume of distribution of the analyte [C-14] BI 1467335 after intravenous administration on Day 1 (Vz).

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Volume of Distribution of the Analyte [C-14] BI 1467335 After Intravenous Administration on Day 1 (Vz)	554 Liter (L) Geometric Coefficient of Variation 128	—

SECONDARY outcome

Timeframe: Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI 1467335 intake on Day 28.

Population: PKS

Volume of distribution of the analyte [C-14] BI 1467335 after intravenous administration on Day 28 (Vz, 28).

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Volume of Distribution of the Analyte [C-14] BI 1467335 After Intravenous Administration on Day 28 (Vz, 28)	204 Liter (L) Geometric Coefficient of Variation 13.4	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken 2 h pre-dose and at 0.25, 0.5, 0.75, 1.083, 1.417, 2, 3, 4, 6 and 8 h after last drug administration on day 1 for BI 1467335.

Population: PKS

Absolute bioavailability (Fabs) of BI 1467335 after oral administration on Day 1, F (absolute bioavailability) on Day 1 determined as ratio Day 1 (AUC 0-∞/Dose)oral/ (AUC0-∞/Dose)iv·100 per subject.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Absolute Bioavailability (Fabs) of BI 1467335 After Oral Administration on Day 1	0.0834 Ratio Geometric Coefficient of Variation 75.9	—

SECONDARY outcome

Timeframe: Within 1.083 before and 0.083, 0.25, 0.417, 0.583, 0.75, 1, 1.25, 1.75, 2.25, 2.75, 3.25, 3.75, 4.25, 6.25, 8.25, 12 and 24, 48 and 96h after [C-14] BI 1467335 intake on Day 28.

Population: PKS

Absolute bioavailability of BI 1467335 after oral administration on Day 28 (Fabs,28), F (absolute bioavailability) on Day 28 determined as ratio Day 28 (AUC 0-∞/Dose)oral/ (AUC0-∞/Dose)iv·100 per subject.

Outcome measures

Measure	BI 1467335 Tab n=12 Participants Participant were administered 2 film-coated tablets of 5 mg (2\*5 mg) of BI 1467335 orally for 28 days (Day 1 to 28).	BI 1467335 (C-14) iv Participant were administered BI 1467335 mixed with BI 1467335 (C-14) intravenously (50 μg BI 1467335 (C-14) in 10 mL saline) as two single iv infusions (Day 1 and Day 28, infused over 15 min, 1 hour after the oral dose.
Absolute Bioavailability of BI 1467335 After Oral Administration on Day 28 (Fabs,28)	0.621 Ratio Geometric Coefficient of Variation 35.1	—

Adverse Events

BI 1467335

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	BI 1467335 n=12 participants at risk All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg \[C-14\] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg \[C-14\] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later.
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Gastrointestinal disorders Nausea	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
General disorders Catheter site pain	16.7% 2/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
General disorders Feeling hot	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
General disorders Medical device site irritation	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Nervous system disorders Dizziness	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Nervous system disorders Headache	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Nervous system disorders Somnolence	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Immune system disorders Seasonal allergy	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Psychiatric disorders Listless	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	8.3% 1/12 • From first day of study drug administration until 12 days after last drug administration, up to 40 days. Treated set (TS): All subjects who received at least one dose of study drug.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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.
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