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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
Part A: oral solution of 14C-OSI-906
Part B: oral tablets OSI-906
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Comprehensive Clinical Development NW, Inc.
Tacoma, Washington, United States
Radioactivity in whole blood and plasma
Outcome measure for Part A: Area under the time concentration curve extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable time point (AUClast), Maximum Plasma Concentration (Cmax), Time to maximum concentration (Tmax), Terminal half-life (t 1/2), Apparent Body Clearance after dosing (CL/F), and Apparent volume of distribution (Vz/F)
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Radioactivity ratio in blood/plasma
Outcome Measure for Part A of OSI-906 distribution between cellular components and plasma
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Excretion ratio and cumulative excretion of radioactivity in urine and feces
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Composite of Pharmacokinetics of OSI-906 in plasma: AUC inf, AUC last, C max, t max, t 1/2, CL/F, and Vz/F
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Composite of Pharmacokinetics of OSI-906 in urine: Cumulative amount of drug excreted into urine, feces or bile up to collection time of last measurable concentration (Ae last), Renal Clearance (CL R), and percentage of dose excreted (Ae last%)
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Metabolic Profile: Profiling of possible metabolites in OSI-906 plasma, urine, and feces
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety as assessed by recording adverse events, laboratory assessments and vital signs, and electrocardiograms (ECGs)
Outcome measures for Part A and Part B
Time frame: For Part A: Days 1-10 and/or 30 days post treatment visit. For Part B: Treatment Period 1 (TP1) through 30 day post treatment visit (up to two years)