Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses (NCT NCT01505894)

Last Updated: 2024-03-08

Results Overview

An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

83 participants

Primary outcome timeframe

From first drug administration until the end-of-trial examination, up to 28 days.

Results posted on

2024-03-08

Participant Flow

This is randomised, placebo control, double blind, phase 1, pharmacokinetic study in healthy young and elderly subjects.

All participants were screened for eligibility to participate in the trial. Participants attended a specialist sites which ensured that they met all of the inclusion and none of exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	BI 409306 25 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	Placebo- Young Subjects Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.	Placebo-Elderly Subjects Once Daily (QD) Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.
Overall Study STARTED	9	9	9	9	8	9	9	12	9
Overall Study COMPLETED	9	9	8	9	8	9	9	11	9
Overall Study NOT COMPLETED	0	0	1	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 409306 25 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	Placebo- Young Subjects Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.	Placebo-Elderly Subjects Once Daily (QD) Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.
Overall Study Adverse Event	0	0	0	0	0	0	0	1	0
Overall Study Other than specified	0	0	1	0	0	0	0	0	0

Baseline Characteristics

Treated Set: Included all subjects who are treated with BI 409306.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo- Young Subjects n=12 Participants Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2.	Placebo-Elderly Subjects Once Daily (QD) n=9 Participants Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days.	BI 409306 25 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	Total n=83 Participants Total of all reporting groups
Age, Continuous Young Subjects	41.8 Years STANDARD_DEVIATION 9.7 • n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	42.2 Years STANDARD_DEVIATION 6.6 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	42.1 Years STANDARD_DEVIATION 8.1 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	41.9 Years STANDARD_DEVIATION 7.9 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	42.2 Years STANDARD_DEVIATION 6.3 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	42.0 Years STANDARD_DEVIATION 7.6 • n=48 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Age, Continuous Elderly Subjects	—	67.6 Years STANDARD_DEVIATION 3.0 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	69.1 Years STANDARD_DEVIATION 3.1 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	—	70.5 Years STANDARD_DEVIATION 4.0 • n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	—	67.9 Years STANDARD_DEVIATION 3.6 • n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	68.7 Years STANDARD_DEVIATION 3.5 • n=35 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Sex: Female, Male Female	4 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	7 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	2 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	5 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	4 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	3 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	6 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	2 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	3 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	36 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Sex: Female, Male Male	8 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	2 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	7 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	4 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	5 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	6 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	2 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	7 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	6 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	47 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) Asian	0 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	1 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	1 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) Black or African American	0 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) White	12 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	9 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	9 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	9 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	8 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	9 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	8 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	9 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	9 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	82 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) More than one race	0 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=8 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=9 Participants • Treated Set: Included all subjects who are treated with BI 409306.	0 Participants n=83 Participants • Treated Set: Included all subjects who are treated with BI 409306.

PRIMARY outcome

Timeframe: From first drug administration until the end-of-trial examination, up to 28 days.

Population: Treated Set (TS): Included all subjects who are treated with BI 409306.

An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=12 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group	6 Participants	3 Participants	5 Participants	6 Participants	4 Participants	8 Participants	5 Participants	8 Participants	8 Participants

PRIMARY outcome

Timeframe: From first drug administration until the end-of-trial examination, up to 28 days.

Population: Treated Set (TS): Included all subjects who are treated with BI 409306.

Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=12 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment Suicidality assessment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment Vital signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment 12-lead ECG	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment Clinical laboratory test	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment Physical examiniation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment Ophthalmological examination	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first drug administration until the end-of-trial examination, up to 28 days.

Population: Treated Set (TS): Included all subjects who are treated with BI 409306.

The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=12 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Number of Participants Per Category of Global Tolerability Assessed by the Investigator Good	11 Participants	9 Participants	9 Participants	9 Participants	9 Participants	9 Participants	8 Participants	9 Participants	8 Participants
Number of Participants Per Category of Global Tolerability Assessed by the Investigator Not satisfactory	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Per Category of Global Tolerability Assessed by the Investigator Bad	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Per Category of Global Tolerability Assessed by the Investigator Not assessable	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Per Category of Global Tolerability Assessed by the Investigator Satisfactory	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first drug administration until the end-of-trial examination, up to 28 days.

Population: Treated Set (TS): Included all subjects who are treated with BI 409306.

Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=12 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Number of Participants With Abnormal Findings in Color Discrimination Test	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first drug administration until the end-of-trial examination, up to 28 days.

Population: Treated Set (TS): Included all subjects who are treated with BI 409306.

Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=12 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Number of Participants With Abnormal Findings in Visual Acuity Test	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.

Population: Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics.

Maximum measured concentration of the BI 409306 in plasma after first dose.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Maximum Concentration of BI 409306 in Plasma (Cmax)	245 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 130	376 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 48.0	565 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 84.6	696 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 47.8	1100 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 58.5	1030 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 79.2	1840 Nanomoles/Litre (nmol/L) Geometric Coefficient of Variation 68.1	—	—

SECONDARY outcome

Timeframe: On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.

Time from dosing to maximum measured concentration of BI 409306 in plasma (Tmax) after the first dose.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax)	0.750 Hour (h) Interval 0.5 to 1.52	0.500 Hour (h) Interval 0.167 to 0.75	0.500 Hour (h) Interval 0.333 to 0.75	0.750 Hour (h) Interval 0.333 to 0.75	0.333 Hour (h) Interval 0.167 to 1.0	0.500 Hour (h) Interval 0.333 to 0.75	0.500 Hour (h) Interval 0.333 to 1.5	—	—

SECONDARY outcome

Timeframe: On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.

Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after first dose.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	548 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 142	594 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 48.6	955 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 97.6	1140 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 54.0	1510 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 70.5	1620 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 60.1	2840 NanomoleHour/Litre (nmolh/L) Geometric Coefficient of Variation 56.1	—	—

SECONDARY outcome

Timeframe: At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.

Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)	348 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 71.4	444 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 44.2	663 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 98.0	596 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 42.8	1250 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 76.6	1260 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 55.4	2150 Nanomole/Litre (nmol/L) Geometric Coefficient of Variation 87.0	—	—

SECONDARY outcome

Time from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14.

Outcome measures

Outcome measures
Measure	BI 409306 25 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 25 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 50 Milligram- Young Subjects (BID) n=9 Participants Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2).	BI 409306 50 Milligram- Elderly Subjects (QD) n=8 Participants Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) n=9 Participants Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) n=9 Participants Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Young Subjects (QD) Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.	BI 409306 100 Milligram- Elderly Subjects (QD) Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days.
Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss)	0.750 Hour (h) Interval 0.333 to 0.783	0.500 Hour (h) Interval 0.333 to 0.75	0.625 Hour (h) Interval 0.333 to 1.02	0.750 Hour (h) Interval 0.5 to 1.0	0.417 Hour (h) Interval 0.167 to 1.5	0.500 Hour (h) Interval 0.333 to 0.75	0.333 Hour (h) Interval 0.167 to 1.5	—	—

SECONDARY outcome

This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose on day 14.