Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers (NCT NCT02057835)

NCT ID: NCT02057835

Last Updated: 2015-12-16

Results Overview

Percentage of participants with drug related adverse events (AEs)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 64 participants
• Primary outcome timeframe: From drug administration until 31 days after drug administration, 31 days
• Results posted on: 2015-12-16

Participant Flow

Participant milestones

Measure	Chinese: Placebo Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Overall Study STARTED	8	6	6	6	6	8	6	6	6	6
Overall Study COMPLETED	8	4	6	6	6	8	6	6	6	6
Overall Study NOT COMPLETED	0	2	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Chinese: Placebo Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Overall Study Withdrawal by Subject	0	2	0	0	0	0	0	0	0	0

Baseline Characteristics

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers

Baseline characteristics by cohort

Measure	Chinese: Placebo n=8 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=6 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=8 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg n=6 Participants Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg n=6 Participants Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Total n=64 Participants Total of all reporting groups
Age, Continuous	25.3 Years STANDARD_DEVIATION 5.06 • n=5 Participants	24.5 Years STANDARD_DEVIATION 3.73 • n=7 Participants	23.0 Years STANDARD_DEVIATION 2.53 • n=5 Participants	26.3 Years STANDARD_DEVIATION 4.55 • n=4 Participants	28.8 Years STANDARD_DEVIATION 4.02 • n=21 Participants	29.5 Years STANDARD_DEVIATION 3.82 • n=10 Participants	31.7 Years STANDARD_DEVIATION 4.76 • n=115 Participants	36.5 Years STANDARD_DEVIATION 2.74 • n=6 Participants	31.0 Years STANDARD_DEVIATION 4.82 • n=6 Participants	34.5 Years STANDARD_DEVIATION 0.84 • n=64 Participants	29.0 Years STANDARD_DEVIATION 5.52 • n=17 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=64 Participants	64 Participants n=17 Participants

PRIMARY outcome

Timeframe: From drug administration until 31 days after drug administration, 31 days

Population: Treated set

Percentage of participants with drug related adverse events (AEs)

Outcome measures

Measure	Chinese: Placebo n=8 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=6 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=8 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg n=6 Participants Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg n=6 Participants Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Percentage of Participants With Drug Related Adverse Events	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Maximum measured concentration of the analyte in plasma/whole blood

Outcome measures

Measure	Chinese: Placebo n=6 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=6 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=6 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Maximum Measured Concentration of the Analyte (Cmax) Plasma	175 nmol/L Geometric Coefficient of Variation 45.7	477 nmol/L Geometric Coefficient of Variation 25.5	1450 nmol/L Geometric Coefficient of Variation 19.4	3690 nmol/L Geometric Coefficient of Variation 20.5	129 nmol/L Geometric Coefficient of Variation 33.2	421 nmol/L Geometric Coefficient of Variation 53.4	1520 nmol/L Geometric Coefficient of Variation 18.1	4270 nmol/L Geometric Coefficient of Variation 9.4	—	—
Maximum Measured Concentration of the Analyte (Cmax) Blood	247 nmol/L Geometric Coefficient of Variation 21.5	523 nmol/L Geometric Coefficient of Variation 19.7	1490 nmol/L Geometric Coefficient of Variation 22.1	3470 nmol/L Geometric Coefficient of Variation 16.4	213 nmol/L Geometric Coefficient of Variation 17.9	509 nmol/L Geometric Coefficient of Variation 35.4	1530 nmol/L Geometric Coefficient of Variation 22.4	3600 nmol/L Geometric Coefficient of Variation 12.4	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)

Outcome measures

Measure	Chinese: Placebo n=12 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=12 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=12 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=12 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Maximum Measured Concentration of the Analyte (Cmax) - Overall Plasma	150 nmol/L Geometric Coefficient of Variation 41.4	448 nmol/L Geometric Coefficient of Variation 39.8	1490 nmol/L Geometric Coefficient of Variation 18.0	3970 nmol/L Geometric Coefficient of Variation 17.0	—	—	—	—	—	—
Maximum Measured Concentration of the Analyte (Cmax) - Overall Blood	229 nmol/L Geometric Coefficient of Variation 20.4	516 nmol/L Geometric Coefficient of Variation 27.2	1510 nmol/L Geometric Coefficient of Variation 21.2	3530 nmol/L Geometric Coefficient of Variation 14.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood

Outcome measures

Measure	Chinese: Placebo n=6 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=6 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=6 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) Plasma	0.333 hours Interval 0.333 to 0.667	0.667 hours Interval 0.333 to 2.0	0.667 hours Interval 0.333 to 1.0	0.667 hours Interval 0.333 to 0.667	0.667 hours Interval 0.333 to 0.667	0.500 hours Interval 0.333 to 0.667	0.667 hours Interval 0.333 to 0.667	0.667 hours Interval 0.333 to 0.683	—	—
Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) Blood	0.333 hours Interval 0.333 to 2.0	0.667 hours Interval 0.333 to 2.0	0.667 hours Interval 0.333 to 1.0	0.667 hours Interval 0.333 to 0.667	0.500 hours Interval 0.333 to 4.0	0.333 hours Interval 0.333 to 0.667	0.667 hours Interval 0.333 to 1.0	0.667 hours Interval 0.333 to 0.683	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)

Outcome measures

Measure	Chinese: Placebo n=12 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=12 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=12 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=12 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall Plasma	0.500 hours Full Range 41.4 • Interval 0.333 to 0.667	0.667 hours Full Range 39.8 • Interval 0.333 to 2.0	0.667 hours Full Range 18.0 • Interval 0.333 to 1.0	0.667 hours Full Range 17.0 • Interval 0.333 to 0.683	—	—	—	—	—	—
Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall Blood	0.333 hours Full Range 20.4 • Interval 0.333 to 4.0	0.500 hours Full Range 27.2 • Interval 0.333 to 2.0	0.667 hours Full Range 21.2 • Interval 0.333 to 1.0	0.667 hours Full Range 14.0 • Interval 0.333 to 0.683	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)

Outcome measures

Measure	Chinese: Placebo n=5 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=6 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=6 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) Plasma (N=0,5,6,6,0,0,6,6)	NA nmol*h/L Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	5280 nmol*h/L Geometric Coefficient of Variation 17.3	18000 nmol*h/L Geometric Coefficient of Variation 22.3	37400 nmol*h/L Geometric Coefficient of Variation 23.9	NA nmol*h/L Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	NA nmol*h/L Geometric Coefficient of Variation NA gMean and gCV were not calculated, since, according to internal rules, descriptive statistics were considered as reliable only when data from at least 2/3 of the subjects were available.	22400 nmol*h/L Geometric Coefficient of Variation 28.0	42000 nmol*h/L Geometric Coefficient of Variation 14.1	—	—
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) Blood (N=5,6,6,6,6,6,6,6)	31600 nmol*h/L Geometric Coefficient of Variation 23.3	51800 nmol*h/L Geometric Coefficient of Variation 22.4	75600 nmol*h/L Geometric Coefficient of Variation 13.5	118000 nmol*h/L Geometric Coefficient of Variation 10.3	35600 nmol*h/L Geometric Coefficient of Variation 65.5	48700 nmol*h/L Geometric Coefficient of Variation 19.6	91800 nmol*h/L Geometric Coefficient of Variation 38.6	105000 nmol*h/L Geometric Coefficient of Variation 11.4	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)

Outcome measures

Measure	Chinese: Placebo n=11 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=12 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=12 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=12 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall Plasma (N=0, 8, 12, 12)	NA nmol*h/L Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	5210 nmol*h/L Geometric Coefficient of Variation 27.8	20100 nmol*h/L Geometric Coefficient of Variation 26.8	39600 nmol*h/L Geometric Coefficient of Variation 19.6	—	—	—	—	—	—
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall Blood (N=11, 12, 12, 12)	33800 nmol*h/L Geometric Coefficient of Variation 47.5	50200 nmol*h/L Geometric Coefficient of Variation 20.4	83300 nmol*h/L Geometric Coefficient of Variation 29.2	112000 nmol*h/L Geometric Coefficient of Variation 12.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)

Outcome measures

Measure	Chinese: Placebo n=4 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=6 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=6 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) Plasma	1320 nmol*h/L Geometric Coefficient of Variation 22.1	4720 nmol*h/L Geometric Coefficient of Variation 17.8	17500 nmol*h/L Geometric Coefficient of Variation 23.1	37000 nmol*h/L Geometric Coefficient of Variation 24.2	1310 nmol*h/L Geometric Coefficient of Variation 27.3	5060 nmol*h/L Geometric Coefficient of Variation 38.7	21600 nmol*h/L Geometric Coefficient of Variation 28.6	41100 nmol*h/L Geometric Coefficient of Variation 13.8	—	—
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) Blood	19200 nmol*h/L Geometric Coefficient of Variation 11.9	27900 nmol*h/L Geometric Coefficient of Variation 9.9	41000 nmol*h/L Geometric Coefficient of Variation 14.6	66600 nmol*h/L Geometric Coefficient of Variation 14.2	19500 nmol*h/L Geometric Coefficient of Variation 22.2	29600 nmol*h/L Geometric Coefficient of Variation 11.1	48300 nmol*h/L Geometric Coefficient of Variation 16.2	66800 nmol*h/L Geometric Coefficient of Variation 9.5	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)

Outcome measures

Measure	Chinese: Placebo n=10 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=12 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=12 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=12 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall Plasma (N=10, 12, 12, 12)	1310 nmol*h/L Geometric Coefficient of Variation 23.9	4890 nmol*h/L Geometric Coefficient of Variation 28.7	19500 nmol*h/L Geometric Coefficient of Variation 27.2	39000 nmol*h/L Geometric Coefficient of Variation 19.6	—	—	—	—	—	—
Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall Blood (N=10, 12, 12, 12)	19400 nmol*h/L Geometric Coefficient of Variation 17.9	28700 nmol*h/L Geometric Coefficient of Variation 10.5	44500 nmol*h/L Geometric Coefficient of Variation 17.1	66700 nmol*h/L Geometric Coefficient of Variation 11.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Terminal half-life (T1/2) of the analyte in plasma/whole blood

Outcome measures

Measure	Chinese: Placebo n=5 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=5 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=6 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=6 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg n=6 Participants Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo n=6 Participants Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg n=6 Participants Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg n=6 Participants Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Terminal Half-life of the Analyte (T1/2) Plasma (N=0,5,6,6,0,0,6,6)	NA hours Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	94.6 hours Geometric Coefficient of Variation 29.8	102 hours Geometric Coefficient of Variation 34.3	73.5 hours Geometric Coefficient of Variation 40.4	NA hours Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	NA hours Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	95.0 hours Geometric Coefficient of Variation 64.7	89.9 hours Geometric Coefficient of Variation 26.2	—	—
Terminal Half-life of the Analyte (T1/2) Blood (N=5,6,6,6,6,6,6,6)	243 hours Geometric Coefficient of Variation 40.6	333 hours Geometric Coefficient of Variation 30.6	393 hours Geometric Coefficient of Variation 23.1	417 hours Geometric Coefficient of Variation 23.7	290 hours Geometric Coefficient of Variation 62.8	265 hours Geometric Coefficient of Variation 26.2	403 hours Geometric Coefficient of Variation 48.9	340 hours Geometric Coefficient of Variation 26.0	—	—

SECONDARY outcome

Timeframe: 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration

Population: All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.

Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)

Outcome measures

Measure	Chinese: Placebo n=11 Participants Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 5mg n=12 Participants Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 10mg n=12 Participants Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 30mg n=12 Participants Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Chinese: BI 691751 60mg Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: Placebo Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 5mg Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 10mg Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 30mg Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	Japanese: BI 691751 60mg Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Terminal Half-life of the Analyte (T1/2) - Overall Plasma (N=0, 8, 12, 12)	NA hours Geometric Coefficient of Variation NA gMean and gCV were not calculated as the concentrations were not quantifiable at the terminal phase and this parameter could not be evaluated in most of subjects.	84.2 hours Geometric Coefficient of Variation 28.9	98.4 hours Geometric Coefficient of Variation 48.4	81.3 hours Geometric Coefficient of Variation 34.1	—	—	—	—	—	—
Terminal Half-life of the Analyte (T1/2) - Overall Blood (N=11, 12, 12, 12)	267 hours Geometric Coefficient of Variation 51.6	297 hours Geometric Coefficient of Variation 29.8	398 hours Geometric Coefficient of Variation 35.9	377 hours Geometric Coefficient of Variation 26.2	—	—	—	—	—	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

BI 691751 5mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

BI 691751 10mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

BI 691751 30mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 691751 60mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=16 participants at risk Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.	BI 691751 5mg n=12 participants at risk Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.	BI 691751 10mg n=12 participants at risk Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.	BI 691751 30mg n=12 participants at risk Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.	BI 691751 60mg n=12 participants at risk Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
Eye disorders Eye pruritus	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Eye disorders Ocular hyperaemia	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days
Gastrointestinal disorders Abdominal discomfort	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Gastrointestinal disorders Constipation	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
General disorders Injection site pain	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
General disorders Pyrexia	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days
Investigations Liver function test abnormal	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Nervous system disorders Headache	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days
Nervous system disorders Somnolence	6.2% 1/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	33.3% 4/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	25.0% 3/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	18.8% 3/16 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days	25.0% 3/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Throat irritation	12.5% 2/16 • From drug administration until 31 days after drug administration, 31 days	25.0% 3/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 1/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Sputum increased	6.2% 1/16 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Sneezing	12.5% 2/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	16.7% 2/12 • From drug administration until 31 days after drug administration, 31 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days
Vascular disorders Orthostatic hypotension	0.00% 0/16 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days	8.3% 1/12 • From drug administration until 31 days after drug administration, 31 days	0.00% 0/12 • From drug administration until 31 days after drug administration, 31 days

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.
• Publication restrictions are in place

Restriction type: OTHER