HealthyPhase 1NCT01608087

Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

A Phase 1 study testing BI 695502 and bevacizumab in people with Healthy, run by Boehringer Ingelheim at 2 sites in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab. Read more about this study

Who is it for?: Ages 21 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 695502 and bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 2 sitesNew Zealand
Study dates: 1 May 2012to 1 Nov 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

1302.1.002 Boehringer Ingelheim Investigational Site
Auckland NZ
1302.1.001 Boehringer Ingelheim Investigational Site
Christchurch

Other trials in New Zealand

About this study

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

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

Conditions: Healthy
Being tested: BI 695502, bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 695502Drug
BI 695502 single i.v. infusion
bevacizumabDrug
bevacizumab single i.v. infusion
bevacizumabDrug
bevacizumab single i.v. infusion

Study groups in NCT01608087
Study group	Role	What they receive
BI 695502	Experimental	Subject to receive one intravenous (i.v.) infusion of BI 695502 Receives: Drug: BI 695502
bevacizumab A	Active comparator	Subject to receive one i.v. infusion of bevacizumab Receives: Drug: bevacizumab
bevacizumab B	Active comparator	Subject to receive one i.v. infusion of bevacizumab Receives: Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
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.
Measured: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion

Secondary outcomes (2)

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.
Measured: 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)
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.
Measured: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20121 Nov 2012

First posted30 May 2012 (estimated)
Study start1 May 2012
Primary completion1 Nov 2012
Study completion1 Nov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01608087
Sponsor's protocol ID: 1302.1
Status last verified: Oct 2019
First submitted: 22 May 2012
Last updated: 8 Nov 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Hettema W, Wynne C, Lang B, Altendorfer M, Czeloth N, Lohmann R, Athalye S, Schliephake D. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. Expert Opin Investig Drugs. 2017 Aug;26(8):889-896. doi: 10.1080/13543784.2017.1347635. Epub 2017 Jul 12.
PubMed 28651442

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01608087
Acronym / sponsor ID: 1302.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 May 2012 (actual)
Primary completion: 1 Nov 2012 (actual)
Study completion: 1 Nov 2012 (actual)
First posted: 30 May 2012 (estimated)
Results: Posted 8 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 3

Arm	Type	Receives
BI 695502	Experimental	Drug: BI 695502Subject to receive one intravenous (i.v.) infusion of BI 695502
bevacizumab A	Active comparator	Drug: bevacizumabSubject to receive one i.v. infusion of bevacizumab
bevacizumab B	Active comparator	Drug: bevacizumabSubject to receive one i.v. infusion of bevacizumab

Who may qualify

Ages: 21 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 695502BI 695502 single i.v. infusion	Drug	BI 695502
bevacizumabbevacizumab single i.v. infusion	Drug	bevacizumab B
bevacizumabbevacizumab single i.v. infusion	Drug	bevacizumab A

Primary outcome

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.

2 secondary outcomes

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
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.

Results and safety

Results posted to the registry on 8 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 695502 (T)	30	30
United States (US)-Licensed Avastin® (R1)	30	28
European Union (EU)-Approved Avastin® (R2)	31	31

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: microgram*hour/milliliter

Measure	BI 695502 (T) n = 30	United States (US)-Licensed Avastin® (R1) n = 30	European Union (EU)-Approved Avastin® (R2) n = 30
Value	7013.010 (19.52)	7261.119 (15.57)	7649.491 (18.29)

BI 695502 (T) vs United States (US)-Licensed Avastin® (R1): gMean ratio: 96.58 (93.93% CI 88.54 to 105.35), ANOVA
BI 695502 (T) vs European Union (EU)-Approved Avastin® (R2): gMean ratio: 91.68 (93.93% CI 83.50 to 100.65), ANOVA
United States (US)-Licensed Avastin® (R1) vs European Union (EU)-Approved Avastin® (R2): gMean ratio: 94.92 (93.93% CI 87.14 to 103.40), ANOVA

Population analysed: Pharmacokinetic (PK) set: The PK set included all subjects in the treated set (subjects who received at least one administration of trial medication) who provided at least one evaluable observation of a PK endpoint and had no important protocol violations relevant to the evaluation of PK biosimilarity.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration to end of trial; up to 99 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 695502 (T)	0 of 30 (0%)	25 of 30 (83.3%)	0 of 30
United States (US)-Licensed Avastin® (R1)	0 of 30 (0%)	19 of 30 (63.3%)	0 of 30
European Union (EU)-Approved Avastin® (R2)	0 of 31 (0%)	21 of 31 (67.7%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28651442Hettema W, Wynne C, Lang B, Altendorfer M, Czeloth N, Lohmann R, Athalye S, Schliephake D. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. Expert Opin Investig Drugs. 2017 Aug;26(8):889-896. doi: 10.1080/13543784.2017.1347635. Epub 2017 Jul 12.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 695502 and bevacizumab in people with Healthy, run by Boehringer Ingelheim at 2 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01608087, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.