Trial Outcomes & Findings for To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers (NCT NCT02093819)

NCT ID: NCT02093819

Last Updated: 2016-03-22

Results Overview

Percentage of subjects with drug-related adverse events

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

AEs were recorded throughout the trial

Results posted on

2016-03-22

Participant Flow

The study was conducted in eight groups.

Participant milestones

Participant milestones
Measure	Placebo The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 10mg The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 25mg The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 50mg The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 100mg The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 200mg The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 400mg The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 600mg The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Overall Study STARTED	15	6	10	6	6	6	5	6
Overall Study COMPLETED	15	6	10	6	6	6	5	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 10mg n=6 Participants The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 25mg n=10 Participants The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 50mg n=6 Participants The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 100mg n=6 Participants The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 200mg n=6 Participants The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 400mg n=5 Participants The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 600mg n=6 Participants The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	Total n=60 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 9.2 • n=99 Participants	35.7 years STANDARD_DEVIATION 7.9 • n=107 Participants	38.9 years STANDARD_DEVIATION 8.7 • n=206 Participants	34.2 years STANDARD_DEVIATION 10.0 • n=7 Participants	31.0 years STANDARD_DEVIATION 4.6 • n=31 Participants	31.2 years STANDARD_DEVIATION 12.7 • n=30 Participants	34.0 years STANDARD_DEVIATION 9.5 • n=3 Participants	35.3 years STANDARD_DEVIATION 10.9 • n=6 Participants	34.5 years STANDARD_DEVIATION 9.1 • n=114 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
Sex: Female, Male Male	15 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants	6 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	5 Participants n=3 Participants	6 Participants n=6 Participants	60 Participants n=114 Participants

PRIMARY outcome

Timeframe: AEs were recorded throughout the trial

Population: The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.

Percentage of subjects with drug-related adverse events

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h	BI 416970 10mg n=6 Participants The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 25mg n=10 Participants The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 50mg n=6 Participants The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 100mg n=6 Participants The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 200mg n=6 Participants The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 400mg n=5 Participants The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 600mg n=6 Participants The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Percentage of Subjects With Drug-related Adverse Events	6.7 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	20.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration

Population: The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.

Cmax (maximum measured concentration of the analyte in plasma)

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h	BI 416970 10mg n=10 Participants The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 25mg n=6 Participants The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 50mg n=6 Participants The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 100mg n=6 Participants The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 200mg n=5 Participants The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 400mg n=5 Participants The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 600mg The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
Cmax (Maximum Measured Concentration of the Analyte in Plasma)	15.2 nmol/L Geometric Coefficient of Variation 66.3	44.0 nmol/L Geometric Coefficient of Variation 80.5	154 nmol/L Geometric Coefficient of Variation 69.6	250 nmol/L Geometric Coefficient of Variation 37.2	482 nmol/L Geometric Coefficient of Variation 40.3	1060 nmol/L Geometric Coefficient of Variation 70.4	1610 nmol/L Geometric Coefficient of Variation 50.2	—

SECONDARY outcome

Timeframe: 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration

Population: The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.

AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h	BI 416970 10mg n=10 Participants The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 25mg n=6 Participants The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 50mg n=6 Participants The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 100mg n=6 Participants The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 200mg n=5 Participants The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 400mg n=5 Participants The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 600mg The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)	72.8 nmol*h/L Geometric Coefficient of Variation 41.5	195 nmol*h/L Geometric Coefficient of Variation 49.8	566 nmol*h/L Geometric Coefficient of Variation 54.0	992 nmol*h/L Geometric Coefficient of Variation 36.1	1770 nmol*h/L Geometric Coefficient of Variation 34.6	3970 nmol*h/L Geometric Coefficient of Variation 61.3	6150 nmol*h/L Geometric Coefficient of Variation 23.2	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=15 participants at risk The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 10 mg n=6 participants at risk The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 25 mg n=10 participants at risk The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 50 mg n=6 participants at risk The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 100 mg n=6 participants at risk The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 200 mg n=6 participants at risk The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 400 mg n=5 participants at risk The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	BI 416970 600 mg n=6 participants at risk The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.	Total BI 416970 Treatment n=45 participants at risk All patients affected by AEs during administration of BI 416970 medication .	Total Treatment n=60 participants at risk All patients affected by AEs during entire treatment period.
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	20.0% 1/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	2.2% 1/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	1.7% 1/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Infections and infestations Nasopharyngitis	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	10.0% 1/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	4.4% 2/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	3.3% 2/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Nervous system disorders Headache	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	10.0% 1/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	20.0% 1/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	8.9% 4/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	6.7% 4/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Nervous system disorders Paraesthesia	6.7% 1/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	1.7% 1/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	10.0% 1/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	2.2% 1/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	1.7% 1/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Infections and infestations Gastrointestinal infection	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	2.2% 1/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	1.7% 1/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Gastrointestinal disorders Nausea	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	2.2% 1/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	1.7% 1/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Gastrointestinal disorders Vomiting	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	16.7% 1/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	4.4% 2/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	3.3% 2/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/10 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	20.0% 1/5 • From the first intake of trial medication until the end of trial examination, up to 14 days.	0.00% 0/6 • From the first intake of trial medication until the end of trial examination, up to 14 days.	2.2% 1/45 • From the first intake of trial medication until the end of trial examination, up to 14 days.	1.7% 1/60 • From the first intake of trial medication until the end of trial examination, up to 14 days.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place