A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 6
Summary
- Conditions
- Advanced Solid Tumors
- Pharmacokinetics of 14C-OSI-906
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study includes two parts: Part A Subjects will be admitted to the clinical research unit on Day -1 and remain confined to the unit until post dosing discharge criteria are met up to a maximum of 10 days. On Day 1, subjects will receive a single oral dose of 14C-labeled OSI-906. Part B (optional...
This study includes two parts: Part A Subjects will be admitted to the clinical research unit on Day -1 and remain confined to the unit until post dosing discharge criteria are met up to a maximum of 10 days. On Day 1, subjects will receive a single oral dose of 14C-labeled OSI-906. Part B (optional) Once the subject has completed part A, the subject may elect to continue participation in Part B. Subjects will receive OSI-906 (non-radiolabeled) twice daily by mouth. Subjects will be seen for scheduled visits every 7 days for the first 36 days and then every 21 days.
Tracking Information
- NCT #
- NCT01529684
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Astellas Pharma Global Development
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