To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose \[14C\] selumetinib in volunteers
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Single oral administration \[C14\] 75mg
Research Site
Ruddington, United Kingdom
Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance
Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Metabolite profiling and identification in plasma and excreta
Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Pharmacokinetic parameters of selumetinib
Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR
Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of selumetinib
Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Safety
Adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis, physical examination, left ventricular ejection fraction, and opthalmology assessments.
Time frame: Assessments prior to treatment and after treatment including follow up.
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