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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655088 Administered by Intravenous Infusion in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 655088

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • SGS Life Science Services - Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BI 655088	Drug: BI 655088

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Drug-related Adverse Events	The number of subjects with drug-related adverse events.	up to 99 days after start of drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured Concentration of BI 655088 in Plasma (Cmax)	Maximum measured concentration of BI 655088 in plasma (Cmax). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.	Up to 2016 hours. See endpoint description for a detailed timeframe.
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	AUC0-tz (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 to the last quantifiable data point). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.	Up to 2016 hours. See endpoint description for a detailed timeframe.
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	AUC0-∞ (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 extrapolated to infinity). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.	Up to 2016 hours. See endpoint description for a detailed timeframe.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1339.1; 2014-002413-29 (EudraCT Number)