NCT01529684

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of 14C-OSI-906 in Subjects With Advanced Solid Tumors With an Optional Treatment Phase

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.

Detailed 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) 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.

Conditions

• Advanced Solid Tumors
• Pharmacokinetics of 14C-OSI-906

Interventions

Type	Name	Description
DRUG	radio-labeled OSI-906	Part A: oral solution of 14C-OSI-906
DRUG	OSI-906	Part B: oral tablets OSI-906

Timeline

• Start date: 2012-03-19
• Primary completion: 2012-12-08
• Completion: 2013-02-20
• First posted: 2012-02-09
• Last updated: 2024-11-07

Locations

2 sites across 1 country: United States