Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]-FZPL in Chinese Patients with Solid Tumor
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
Patients will receive single dose of orally \[14C\]- Fluzoparib on Day 1.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The distribution of Fluzoparib in the whole blood and plasma and whole.radioactive pharmacokinetics following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
The percentage of radioactive dose of \[14C\] radiolabelled Fluzoparib recovered in blood and in total, up to Day 10 (approx).
Time frame: Up to 10 days (approx) from the start of administration.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor to obtain the mass balance data and the main excretion pathway in human body.
The percentage of radioactive dose of \[14C\] radiolabelled Fluzoparib recovered in urine, faeces and in total, up to Day 10 (approx).
Time frame: Up to 10 days (approx) from the start of administration.
Identification of the main metabolite and biotransformation pathway of Fluzoparib and investigation of metabolite with proportion >10% in plasma following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Proportion of different metabolites.
Time frame: Up to 10 days (approx) from the start of administration.
Quantitive analysis of the concentrations of Fluzoparib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
The concentrations of Fluzoparib in plasma up to Day 10.
Time frame: Up to 10 days (approx) from the start of administration.
Observation of safety following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Adverse events assessed by CTCAE v5.0.
Time frame: Up to 10 days (approx) from the start of administration.
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