An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
- Registration Number
- NCT01161836
- Lead Sponsor
- Sanofi
- Brief Summary
This is a Phase 1, multi-center, open-label study.
During Segment 1, patients are administered a single IV administration of \[14C\]-iniparib.
During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iniparib Iniparib Segment 1: 400 mg \[14C\]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy
- Primary Outcome Measures
Name Time Method The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib Up to 35 days The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. Up to 35 days The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity up to 35 days The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration 96 hours
- Secondary Outcome Measures
Name Time Method The clinical and biological tolerability of iniparib. During treatment and until 30 days post treatment
Trial Locations
- Locations (1)
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States