Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01608087
First received: May 22, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BI 695502
Drug: bevacizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: up to 99 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: up to 99 days ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma [ Time Frame: up to 99 days ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608087

Locations
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
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01608087     History of Changes
Other Study ID Numbers: 1302.1
Study First Received: May 22, 2012
Last Updated: May 15, 2013
Health Authority: New Zealand: Medsafe

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014