Phase 1
Completed N=48
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080
Healthy
Source: ClinicalTrials.gov NCT04666922 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Percentage of Subjects With Drug-related Adverse Events — 0; 0; 0; 0 Percentage of Participants
Summary
The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 765080 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
4950; 258000; 973000; 2530000; 7180000; 14900000 | — |
| SECONDARY Maximum Measured Concentration of BI 765080 in Serum (Cmax) |
274; 3490; 8230; 16900; 35400; 64500 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (inclusive)
- BMI of 18.5 to 29.9 kg/m2 (inclusive)
- 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, PR or ECG) deviating from normal and assessed 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 assessed 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 or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- A positive poly chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and clinical symptoms suggestive for this disease on Day -2.
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04666922). 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. Informational only — not medical advice.