Site Reference ID/Investigator# 51403
Tacoma, Washington, 98405, United States
NCT Number: NCT01381341
A pharmacokinetic study to compare 2 clinical formulations of linifanib.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Tacoma, Washington, 98405, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
QD on Day 1 of Periods 1 and 2
Other names: ABT-869
Time frame: At various time points from Day 1 through Day 5 of Periods 1 and 2
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.
Time frame: Throughout the study
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.
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.
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.
Time frame: Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up.
Chemistry, hematology, urinalysis lab tests
Abbott
Industry
A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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