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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525679
• Other study ID #: 1368.1
• Secondary ID: 2015-001931-19
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2015
• Est. completion date: May 27, 2016

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 27, 2016
• Est. primary completion date: May 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 655130 (spesolimab)

• Placebo

Locations

Country	Name	City	State
Belgium	SGS Life Science Services - Clinical Research	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Drug Related Adverse Events	Percentage of subjects with drug related adverse events are presented.	Adverse events reported until the end-of-trial examination; up to day 74
Secondary	Maximum Measured Concentration of BI 655130 in Plasma (Cmax)	Maximum measured concentration of BI 655130 in plasma (Cmax) is presented.	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
Secondary	Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8)	Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8) is presented.; Reliable values of AUC0-8 could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-8.	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration
Secondary	Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz)	Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented.	-2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration

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