Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000303943
Ethics application status
Approved
Date submitted
18/03/2011
Date registered
22/03/2011
Date last updated
22/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of a High fat Meal on Brivanib in Normal Healthy Subjects.
Scientific title
A Phase 1 Study to determine the effect of a high fat meal on the pharmacokinetics of Brivanib in Healthy Subjects.
Secondary ID [1] 259810 0
Nil
Universal Trial Number (UTN)
U1111-1120-0905
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study will be performed in healthy volunteers. This study is investigating the effect of a high fat meal on the use of a drug for cancer. 261391 0
Condition category
Condition code
Other 265565 265565 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open-label, randomized, 2-period, 2-treatment crossover study in healthy volunteers. Each subject will receive Treatment A: brivanib alaninate 800 mg (2 x 400 mg tablets) as a single oral dose under
fasted conditions AND Treatment B: brivanib alaninate 800 mg (2 x 400 mg tablets) as a single oral dose within 5 minutes of consuming a standard high-fat breakfast. There will be at least a 7 day washout between each treatment.
Intervention code [1] 264240 0
Treatment: Drugs
Comparator / control treatment
Each participant will be given both treatment A and treatment B over the course of the study.
Treatment A: brivanib alaninate 800 mg under
fasted conditions. (Intervention treatment)
Treatment B: brivanib alaninate 800 mg within 5 minutes of consuming a standard high-fat breakfast (Comparator treatment)
A standard high fat breakfast consists of 2 fried eggs, 2 slices of toasted white bread, 1 tablespoon butter, 1 tablespoon jam, 3 strips fried bacon, hash brown potatoes and one glass full cream milk.
Control group
Active

Outcomes
Primary outcome [1] 262354 0
The primary outcome is to assess the effect of a high-fat meal on the PK of brivanib in healthy subjects.
Timepoint [1] 262354 0
This will be measured via blood analysis at multiple time points on Days 1, 2, 3, 8, 9 and 10.
Secondary outcome [1] 273614 0
To further describe the safety and tolerability of brivanib alaninate under fasted and fed conditions measured through safety laboratory assessments and observation throughout the study.
Timepoint [1] 273614 0
Safety laboratory assessments will be performed via blood sampling. Each participant will also be asked questioned 3-4 times daily and observed by the study team throughout the inpatient stay to determine if any adverse events have been experienced. Blood pressure, heart rate and temperature, along with ECG measurements will also be taken 4-5 times throughout the study to confirm participant safety.
Secondary outcome [2] 273615 0
To assess the effect of plasma collection matrix on measurement of brivanib concentrations (tubes with glycine versus no glycine stabilizer). This will be evaluated at multiple time points on Days 1, 2, 3, 8, 9 and 10.
Timepoint [2] 273615 0
This will be evaluated at multiple time points on Days 1, 2, 3, 8, 9 and 10 by blood analysis.

Eligibility
Key inclusion criteria
Healthy Men and Women aged 18-55 years inclusive.
Women who are not of child bearing potential
Body Mass Index of 18.0-30.0 kg/m2 inclusive
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any significant acute or chronic illness.
Any clinically significant illness, laboratory findings or allergies.
History of hypertension (> 140/90 mmHg consistently on two separate measurements without treatment).
Inability to tolerate oral medication.
Inability to be repetitively venipunctured and/or tolerate venous access.
Any history of cardiovascular disease including congestive heart failure of any grade, thromboembolic disease, myocardial infarction, any angina, stroke, transient ischemic attack, or any other ischemic event or symptoms (eg,intermittent claudication).
Resting heart rate less than 45 beats per minute.
Resting blood pressure greater than 140/90 mmHg.
Any of the following on 12-lead ECG prior to study drug administration,confirmed by repeat:
i) PR greater than or equal to 210 millisecond (msec)
ii) QRS greater than or equal to 120 msec
iii) QT greater than or equal to 500 msec
iv) QTcF greater than or equal to 450 msec
Current use of tobacco (eg, smoker, chew) or recent history (within 1 month of screening) of regular tobacco use or a nicotine replacement product.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomized to 1 of 2 treatment sequences according to a computer generated randomization scheme
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264696 0
Commercial sector/Industry
Name [1] 264696 0
Bristol-Myers Squibb Australia
Country [1] 264696 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Australia
Address
PO Box 39
Noble Park, VIC, 3174
Country
Australia
Secondary sponsor category [1] 263828 0
None
Name [1] 263828 0
Address [1] 263828 0
Country [1] 263828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266688 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 266688 0
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Ethics committee country [1] 266688 0
Australia
Date submitted for ethics approval [1] 266688 0
21/02/2011
Approval date [1] 266688 0
Ethics approval number [1] 266688 0

Summary
Brief summary
This study is being run to determine if eating a high fat breakfast will change the way that the body absorbs brivanib. Brivanib is a drug being developed for use in patients with cancer.
Based on previous studies performed with this drug, a high fat meal is not expected to change the way that the body absorbs brivanib.
The study will involve each participant in the study being given a single dose of brivanib whilst fasted and 7 days later being given a single dose of brivanib following consumption of a high fat breakfast. Following each dose, participants will have numerous blood samples collected to determine the levels of brivanib present in the blood and to perform standard laboratory testing to ensure the safety of the participants.
Participants will also have their blood pressure, heart rate and temperature monitored; along with ECG monitoring, physical examinations and general observation throughout the in-patient stay to ensure participant safety.
Participants will be required to be inpatients for 3 nights for each treatment and there must be at least 7 days between each dose of brivanib.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 32356 0
Address 32356 0
Country 32356 0
Phone 32356 0
Fax 32356 0
Email 32356 0
Contact person for public queries
Name 15603 0
Annette Leahy
Address 15603 0
Nucleus Network
5th Flr, Burnet Tower
AMREP Precinct, 89 Commercial Road
Melbourne, Victoria 3004
Country 15603 0
Australia
Phone 15603 0
+61 3 9076 9005
Fax 15603 0
+61 3 9076 8911
Email 15603 0
A.Leahy@nucleusnetwork.com.au
Contact person for scientific queries
Name 6531 0
A/Prof Peter Hodsman
Address 6531 0
Nucleus Network
5th Flr, Burnet Tower
AMREP Precinct, 89 Commercial Road
Melbourne, Victoria 3004
Country 6531 0
Australia
Phone 6531 0
+61 3 9076 8960
Fax 6531 0
+61 3 9076 8911
Email 6531 0
P.Hodsman@nucleusnetwork.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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