Phase 1
N=47
Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02696616 ↗Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Jan 2023
Primary outcome: Primary: Number of Subjects With Drug-related Adverse Events — 2; 1; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 655088 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Drug-related Adverse Events |
2; 1; 2; 1; 0; 0 | — |
| SECONDARY Maximum Measured Concentration of BI 655088 in Plasma (Cmax) |
0.593; 1.69; 5.76; 13.1; 17.3; 48.8 | — |
| 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) |
12.5; 63.8; 392; 1250; 2360; 7210 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) |
12.9; 65.7; 395; 1250; 2360; 7010 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02696616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.