Healthy Clinical Trial
Official title:
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)
Verified date | April 2022 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 47 |
Est. completion date | February 14, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | SGS Life Science Services - Clinical Research | Edegem |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | AUC0-8 (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. |
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