Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT02525679
• Date of registration: 14/08/2015
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
• Scientific title: Single-blind, Partially Randomised, Placebo-controlled Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous Doses of BI 655130 in Healthy Male Volunteers
• Date of first enrolment: September 2015
• Target sample size: 78
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02525679
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

- Healthy male subjects according to the investigators assessment, based on a complete
medical history including a physical examination, vital signs (BP - Blood Pressure,
PR - Puls Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests

- Age of 18 to 45 years (incl.)

- BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.)

- Signed and dated written informed consent prior to admission to the study in
accordance with GCP and local legislation

Exclusion criteria:

- Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse
Rate or ECG - Electrocardiogram) is 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,
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

- Cholecystectomy and/or surgery of the gastrointestinal tract (except appendectomy and
simple hernia repair)

- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders

- Further exclusion criteria apply



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo

Drug: BI 655130

Primary Outcome(s)

Number of subjects with drug related adverse events [Time Frame: up to 1680 hours]

Secondary Outcome(s)

AUC0-infinitiy (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Time Frame: up to 1680 hours]

Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 1680 hours]

Secondary ID(s)

2015-001931-19

1368.1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors