The Effect of a High fat Meal on Brivanib in Normal Healthy Subjects.

A Phase 1 Study to determine the effect of a high fat meal on the pharmacokinetics of Brivanib in Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000303943

Enrollment

Registered

2011-03-22

Start date

2011-03-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

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.

Outcome results