Phase 1
Completed N=91
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01608087 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). — 7013.010; 7261.119; 7649.491 microgram*hour/milliliter
Summary
This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). |
7013.010; 7261.119; 7649.491 | — |
| SECONDARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) |
6570.047; 6639.315; 7167.313 | — |
| SECONDARY Maximum Measured Concentration of the Analyte in Plasma (Cmax) |
23.783; 23.425; 25.505 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males.
- Complete medical history, including physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Aged 21 to 50 years.
- Body mass index below or equal to 30.
- Body weight 65 to 95 kg, inclusive.
Exclusion criteria
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
- Any evidence of a clinically relevant concomitant disease, as judged by the investigator.
- History of relevant orthostatic hypotension, fainting spells, or blackouts.
- Chronic or relevant acute infections.
- History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients).
- Intake of prescribed or over-the-counter drugs within less than 6 half-lives of the respective drug prior to study drug administration or during the trial.
- Participation in another trial with a study medication within two months prior to administration or during the trial (six half-lives).
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day).
- Inability to refrain from smoking during days of confinement at the study center.
- Current alcohol abuse as judged by the investigator.
- Current drug abuse, as judged by the investigator.
Data sourced from ClinicalTrials.gov (NCT01608087). 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.