Clinical trial NCT01608087: Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Official title: Pharmacokinetics and Safety of BI 695502 in Healthy Subjects: a Randomized, Single-blind, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 91
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.


Eligibility criteria: Inclusion criteria:

1. Healthy males.
2. Complete medical history, including physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
3. Aged 21 to 50 years.
4. Body mass index below or equal to 30.
5. Body weight 65 to 95 kg, inclusive.

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
2. Any evidence of a clinically relevant concomitant disease, as judged by the investigator.
3. History of relevant orthostatic hypotension, fainting spells, or blackouts.
4. Chronic or relevant acute infections.
5. History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients).
6. 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.
7. Participation in another trial with a study medication within two months prior to administration or during the trial (six half-lives).
8. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day).
9. Inability to refrain from smoking during days of confinement at the study center.
10. Current alcohol abuse as judged by the investigator.
11. Current drug abuse, as judged by the investigator.

Primary outcomes:
measure: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
timeFrame: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Secondary outcomes:
measure: 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)
timeFrame: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
measure: Maximum Measured Concentration of the Analyte in Plasma (Cmax)
timeFrame: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.
Other outcomes:
Locations:
city: Auckland NZ
country: New Zealand
facility: 1302.1.002 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1302.1.001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Hettema W, Wynne C, Lang B, Altendorfer M, Czeloth N, Lohmann R, Athalye S, Schliephake D. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. Expert Opin Investig Drugs. 2017 Aug;26(8):889-896. doi: 10.1080/13543784.2017.1347635. Epub 2017 Jul 12.