Trial Outcomes & Findings for Safety Tolerability and Pharmacokinetic of BI 411034 (NCT NCT01581684)

Results Overview

Number of participants with drug related adverse events (AEs)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

From drug administration until end of trial examination, up to 13 days

Results posted on

2017-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo EM A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	2mg EM Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Placebo PM A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	20/60mg PM Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
Overall Study STARTED	14	6	6	6	6	6	6	6	1	5
Overall Study COMPLETED	14	6	6	6	6	6	6	6	0	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo EM A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	2mg EM Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Placebo PM A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	20/60mg PM Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
Overall Study Other reason not defined	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

Safety Tolerability and Pharmacokinetic of BI 411034

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo EM n=14 Participants A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	2mg EM n=6 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Placebo PM n=1 Participants A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	20/60mg PM n=5 Participants Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers	Total n=62 Participants Total of all reporting groups
Age, Continuous	38.4 years STANDARD_DEVIATION 6.3 • n=99 Participants	35.5 years STANDARD_DEVIATION 9.9 • n=107 Participants	39.8 years STANDARD_DEVIATION 4.3 • n=206 Participants	38.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	38.3 years STANDARD_DEVIATION 8.2 • n=31 Participants	39.5 years STANDARD_DEVIATION 3.1 • n=30 Participants	32.7 years STANDARD_DEVIATION 5.4 • n=3 Participants	43.8 years STANDARD_DEVIATION 6.7 • n=6 Participants	31.0 years STANDARD_DEVIATION NA • n=114 Participants	42.4 years STANDARD_DEVIATION 8.6	38.6 years STANDARD_DEVIATION 7.1 • n=19 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	6 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	6 Participants n=3 Participants	6 Participants n=6 Participants	1 Participants n=114 Participants	5 Participants	62 Participants n=19 Participants

PRIMARY outcome

Timeframe: From drug administration until end of trial examination, up to 13 days

Population: Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment

Number of participants with drug related adverse events (AEs)

Outcome measures

Outcome measures
Measure	2mg EM n=14 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	20mg PM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=1 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers	20mg PM n=5 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Number of Participants With Drug Related AEs	1 participants	0 participants	0 participants	1 participants	1 participants	1 participants	2 participants	3 participants	0 participants	0 participants	2 participants

PRIMARY outcome

Timeframe: From drug administration until end of trial examination, up to 13 days

Population: Treated set

Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).

Outcome measures

Outcome measures
Measure	2mg EM n=14 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	20mg PM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=1 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers	20mg PM n=5 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Population: PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK

Maximum measured concentration of the analyte (BI 411034) in plasma

Outcome measures

Outcome measures
Measure	2mg EM n=6 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	20mg PM n=5 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers	20mg PM Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Maximum Measured Concentration (Cmax )	61.7 nmol/L Geometric Coefficient of Variation 34.0	236 nmol/L Geometric Coefficient of Variation 55.9	566 nmol/L Geometric Coefficient of Variation 22.0	629 nmol/L Geometric Coefficient of Variation 53.9	2630 nmol/L Geometric Coefficient of Variation 38.8	4610 nmol/L Geometric Coefficient of Variation 51.4	6600 nmol/L Geometric Coefficient of Variation 15.3	935 nmol/L Geometric Coefficient of Variation 17.1	2890 nmol/L Geometric Coefficient of Variation 36.5	—	—

SECONDARY outcome

Timeframe: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Population: PK analysis set

Time from dosing to maximum measured concentration

Outcome measures

Outcome measures
Measure	2mg EM n=6 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	20mg PM n=5 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers	20mg PM Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Time to Maximum Measured Concentration (Tmax)	0.5 h Interval 0.5 to 0.52	0.63 h Interval 0.48 to 1.5	0.63 h Interval 0.5 to 1.0	1.00 h Interval 0.75 to 1.5	0.62 h Interval 0.33 to 0.75	0.62 h Interval 0.48 to 1.02	0.63 h Interval 0.5 to 0.77	0.75 h Interval 0.5 to 1.0	0.50 h Interval 0.33 to 3.0	—	—

SECONDARY outcome

Timeframe: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Population: PK analysis set

Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity

Outcome measures

Outcome measures
Measure	2mg EM n=6 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	20mg PM n=5 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers	20mg PM Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)	134 nmol*h/L Geometric Coefficient of Variation 54.3	729 nmol*h/L Geometric Coefficient of Variation 96.4	1410 nmol*h/L Geometric Coefficient of Variation 18.1	1900 nmol*h/L Geometric Coefficient of Variation 66.2	6140 nmol*h/L Geometric Coefficient of Variation 53.6	13300 nmol*h/L Geometric Coefficient of Variation 70.6	19700 nmol*h/L Geometric Coefficient of Variation 47.7	6240 nmol*h/L Geometric Coefficient of Variation 14.8	18500 nmol*h/L Geometric Coefficient of Variation 13.1	—	—

SECONDARY outcome

Timeframe: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Population: PK analysis set

Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.

Outcome measures

Outcome measures
Measure	2mg EM n=6 Participants Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 Participants Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 Participants Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 Participants Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 Participants Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 Participants Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 Participants Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	20mg PM n=5 Participants Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 Participants Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers	20mg PM Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)	77.6 nmol Geometric Coefficient of Variation 50.3	290 nmol Geometric Coefficient of Variation 22.1	530 nmol Geometric Coefficient of Variation 38.2	860 nmol Geometric Coefficient of Variation 34.1	2070 nmol Geometric Coefficient of Variation 38.8	3390 nmol Geometric Coefficient of Variation 44.6	4520 nmol Geometric Coefficient of Variation 25.9	1220 nmol Geometric Coefficient of Variation 30.3	3080 nmol Geometric Coefficient of Variation 22.1	—	—

Deaths: 0 deaths

60mg PM

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo EM n=14 participants at risk A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)	2mg EM n=6 participants at risk Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers	8mg EM n=6 participants at risk Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers	20mg EM n=6 participants at risk Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers	40mg EM n=6 participants at risk Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers	80mg EM n=6 participants at risk Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers	150mg EM n=6 participants at risk Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers	250mg EM n=6 participants at risk Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers	Placebo PM n=1 participants at risk A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)	20mg PM n=5 participants at risk Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers	60mg PM n=5 participants at risk Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
Eye disorders Chromatopsia	0.00% 0/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days
Eye disorders Photophobia	0.00% 0/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	20.0% 1/5 • From drug administration until end of trial examination, up to 13 days
Gastrointestinal disorders Nausea	0.00% 0/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days
General disorders Feeling drunk	7.1% 1/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days
Infections and infestations Nasopharyngitis	0.00% 0/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	20.0% 1/5 • From drug administration until end of trial examination, up to 13 days
Nervous system disorders Headache	0.00% 0/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	33.3% 2/6 • From drug administration until end of trial examination, up to 13 days	33.3% 2/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	100.0% 1/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	20.0% 1/5 • From drug administration until end of trial examination, up to 13 days
Psychiatric disorders Euphoric mood	0.00% 0/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	16.7% 1/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 1/14 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/6 • From drug administration until end of trial examination, up to 13 days	0.00% 0/1 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days	0.00% 0/5 • From drug administration until end of trial examination, up to 13 days

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place