Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BI 655088

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02696616

2014-002413-29 (EudraCT Number)

1339.1

Details and patient eligibility

About

Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing

Enrollment

47 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects
Age of 18 to 50 years
Body mass index (BMI) of 18.5 to 29.9 kg/m2
Additional inclusion criteria may apply

Exclusion criteria

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
Additional exclusion criteria may apply