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Completed

NCT Number: NCT01608087

Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1302.1.002 Boehringer Ingelheim Investigational Site, Auckland NZ, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 695502

Drug

BI 695502 single i.v. infusion

Bevacizumab

Drug

bevacizumab single i.v. infusion

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics and Safety of BI 695502 in Healthy Subjects: a Randomized, Single-blind, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 30, 2012
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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