Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Pharmacokinetics and Safety of BI 695502 in Healthy Subjects: a Randomized, Single-blind, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study
1 other identifier
interventional
91
1 country
2
Brief Summary
This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2012
Typical duration for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
November 8, 2019
CompletedNovember 8, 2019
October 1, 2019
6 months
May 22, 2012
October 21, 2019
October 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment were made for treatment effect and weight.
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 (2)
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)
Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Maximum Measured Concentration of the Analyte in Plasma (Cmax)
Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.
Study Arms (3)
BI 695502
EXPERIMENTALSubject to receive one intravenous (i.v.) infusion of BI 695502
bevacizumab A
ACTIVE COMPARATORSubject to receive one i.v. infusion of bevacizumab
bevacizumab B
ACTIVE COMPARATORSubject to receive one i.v. infusion of bevacizumab
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
1302.1.002 Boehringer Ingelheim Investigational Site
Auckland NZ, New Zealand
1302.1.001 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
Related Publications (1)
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.
PMID: 28651442DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2012
First Posted
May 30, 2012
Study Start
May 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 8, 2019
Results First Posted
November 8, 2019
Record last verified: 2019-10