NCT01381341CompletedPhase 1
A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.
Study Overview
Brief Summary
A pharmacokinetic study to compare 2 clinical formulations of linifanib.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
linifanib
Experimental
Intervention: linifanib (Drug)
Outcomes
Primary Outcomes
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
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.
Secondary Outcomes
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.(Throughout 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.(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.)
- Safety: Clinical Lab Tests will be performed for each participant as a safety measure.(Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up.)
Investigators
Study Sites (1)
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