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

Phase 1

Completed

• Conditions: 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.; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12611000303943
• Lead Sponsor: Bristol-Myers Squibb Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is to assess the effect of a high-fat meal on the PK of brivanib in healthy subjects.[This will be measured via blood analysis at multiple time points on Days 1, 2, 3, 8, 9 and 10.]

Secondary Outcome Measures

Name	Time	Method
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.[This will be evaluated at multiple time points on Days 1, 2, 3, 8, 9 and 10 by blood analysis.];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.[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.]