Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Linifanib; Drug: Rifampin

• Registration Number: NCT01401933
• Lead Sponsor: Abbott

Brief Summary

This is a phase 1, open-label study designed to determine the interaction of rifampin with linifanib.

Detailed Description

This study is designed to explore the drug interaction between rifampin and linifanib to determine the potential effect of rifampin on the metabolism of linifanib. Linifanib will be taken alone or in combination with rifampin. The safety of a single dose administration of linifanib when administered alone and in combination with rifampin will be assessed. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Study Timeline

• Study First Submitted: 2011-04-29
• Study Start: 2011-05
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-26
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-31
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linifanib	Linifanib	-
Linifanib	Rifampin	-

Primary Outcome Measures

Name	Time	Method
To investigate the effect of rifampin on the pharmacokinetic of linifanib in subjects with advanced or metastatic solid tumors.	Blood samples for the PK of linifanib will be collected at various time points from Day 1 through Day 17.	To assess the effect of rifampin on the pharmacokinetics of linifanib and metabolite(s), an analysis will be performed for the natural logarithms of Cmax and AUC of linifanib and metabolite(s) with concentrations that permit confident determination of values of the pharmacokinetic variables. A paired t-test will be performed to compare the central value on Study Day 13 (with rifampin) to that on Study Day 1 (without rifampin). Point estimates and 90% confidence intervals will also be provided.

Secondary Outcome Measures

Name	Time	Method
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.	Through out the study	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.	Physical exam will be done at Screening, Day1, Day 13, Day 17/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 and Day 1. A symptom-directed physical exam, including weight, will be done at Day 13, Day 17/Final Visit and 30 day safety follow-up.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.	Screening, Day 1, Day 13, Day 17/Final Visit and 30 day safety follow up visit.	Chemistry, hematology, urinalysis lab tests.

Trial Locations

Locations (2)

Site Reference ID/Investigator# 49952; 🇺🇸 Madison, Wisconsin, United States

Site Reference ID/Investigator# 49953; 🇺🇸 Tucson, Arizona, United States