Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 695502; Drug: bevacizumab

• Registration Number: NCT01608087
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-01
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-30
• Primary Completion: 2012-11-01
• Study Completion: 2012-11-01
• Status Verified: 2019-10
• Results First Submitted: 2019-10-21
• Results First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-21
• Results First Posted: 2019-11-08
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 91

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 695502	BI 695502	Subject to receive one intravenous (i.v.) infusion of BI 695502
bevacizumab B	bevacizumab	Subject to receive one i.v. infusion of bevacizumab
bevacizumab A	bevacizumab	Subject to receive one i.v. infusion of bevacizumab

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).	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

Name	Time	Method
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	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.
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.	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.

Trial Locations

Locations (2)

1302.1.002 Boehringer Ingelheim Investigational Site; 🇳🇿 Auckland NZ, New Zealand

1302.1.001 Boehringer Ingelheim Investigational Site; 🇳🇿 Christchurch, New Zealand