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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01608087




Registration number
NCT01608087
Ethics application status
Date submitted
22/05/2012
Date registered
30/05/2012
Date last updated
8/11/2019

Titles & IDs
Public title
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Scientific title
Pharmacokinetics and Safety of BI 695502 in Healthy Subjects: a Randomized, Single-blind, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study
Secondary ID [1] 0 0
1302.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 695502
Treatment: Drugs - bevacizumab
Treatment: Drugs - bevacizumab

Experimental: BI 695502 - Subject to receive one intravenous (i.v.) infusion of BI 695502

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

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


Treatment: Drugs: BI 695502
BI 695502 single i.v. infusion

Treatment: Drugs: bevacizumab
bevacizumab single i.v. infusion

Treatment: Drugs: bevacizumab
bevacizumab single i.v. infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8).
Timepoint [1] 0 0
Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Secondary outcome [2] 0 0
Maximum Measured Concentration of the Analyte in Plasma (Cmax)
Timepoint [2] 0 0
Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.

Eligibility
Key inclusion 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.
Minimum age
21 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland NZ
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish
pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01608087
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01608087