To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.
A pharmacokinetic study to compare 2 clinical formulations of linifanib.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors|
- To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors. [ Time Frame: At various time points from Day 1 through Day 5 of Periods 1 and 2 ] [ Designated as safety issue: No ]Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.
- Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [ Time Frame: Physical exam at Screening, Day 1 of Periods 1 and 2 and Day 5, Period 2/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits. ] [ Designated as safety issue: Yes ]Complete physical exam, including body weight, will be done at Screening. A symptom-directed physical exam, including bodyweight, will be done at Day 1, Periods 1 and 2, Day 5, Period 2/Final Visit and 30 day safety follow-up.
- Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [ Time Frame: Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up. ] [ Designated as safety issue: Yes ]Chemistry, hematology, urinalysis lab tests
|Study Start Date:||May 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
QD on Day 1 of Periods 1 and 2
Other Name: ABT-869
This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381341
|United States, Washington|
|Site Reference ID/Investigator# 51403|
|Tacoma, Washington, United States, 98405|
|Study Director:||Mark D. McKee, MD||Abbott|