Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608087
• Other study ID #: 1302.1
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2012
• Est. completion date: November 1, 2012

Study information

• Verified date: October 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 1, 2012
• Est. primary completion date: November 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 695502
BI 695502 single i.v. infusion
• bevacizumab
bevacizumab single i.v. infusion
• bevacizumab
bevacizumab single i.v. infusion

Locations

Country	Name	City	State
New Zealand	1302.1.002 Boehringer Ingelheim Investigational Site	Auckland NZ
New Zealand	1302.1.001 Boehringer Ingelheim Investigational Site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8).	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8) 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	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)	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.	Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Secondary	Maximum Measured Concentration of the Analyte in Plasma (Cmax)	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.	Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.

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