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Trial record 2 of 96 for:    BI 695502

Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01608087
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 695502 Drug: bevacizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : November 1, 2012
Actual Study Completion Date : November 1, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: BI 695502
Subject to receive one intravenous (i.v.) infusion of BI 695502
Drug: BI 695502
BI 695502 single i.v. infusion

Active Comparator: bevacizumab A
Subject to receive one i.v. infusion of bevacizumab
Drug: bevacizumab
bevacizumab single i.v. infusion

Active Comparator: bevacizumab B
Subject to receive one i.v. infusion of bevacizumab
Drug: bevacizumab
bevacizumab single i.v. infusion




Primary Outcome Measures :
  1. Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). [ Time Frame: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion ]
    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 is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight.

  2. Maximum Measured Concentration of the Analyte in Plasma (Cmax) [ Time Frame: 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) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608087


Locations
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New Zealand
1302.1.002 Boehringer Ingelheim Investigational Site
Auckland NZ, New Zealand
1302.1.001 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] January 11, 2013
Statistical Analysis Plan  [PDF] December 13, 2012

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01608087    
Other Study ID Numbers: 1302.1
First Posted: May 30, 2012    Key Record Dates
Results First Posted: November 8, 2019
Last Update Posted: November 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors