N/A, as Healthy Volunteers Clinical Trial
Official title:
A Single-Center, Open-Label Study of Excretion Balance, Pharmacokinetics, and Metabolism of 14C-Labeled Tozadenant After 240 mg Single Oral Dose Administration in Healthy Male Subjects
The purpose of the study is to investigate how tozadenant is absorbed, distributed, broken down and eliminated from the body. The compound to be administered will be radiolabeled. This enables the investigator to trace the compound in blood, urine, feces, expired air and track what happens to it.
PD0026 is a Phase 1, single-center, open-label, single-dose study to investigate the
absorption, distribution, metabolism, and excretion (ADME) of 14C-labeled tozadenant. The
primary objective is to determine the mass balance and the pharmacokinetics (PK) of total
radioactivity in 6 healthy male subjects following a single oral dose of 14C-labeled
tozadenant. Secondary objectives are to determine the PK of Tozadenant, to identify and
quantify metabolites of tozadenant, and to gain further information on the tolerability and
safety of tozadenant.
The variables related to the radiocarbon activity include the total radioactivity
concentration in whole blood and plasma; the total radioactivity excretion in urine, feces,
and expired air; and the corresponding PK parameters.
The concentrations and the corresponding PK parameters of tozadenant over time will be
determined in plasma, urine, and feces.
In addition, the metabolites of tozadenant will be identified and quantified. The safety and
tolerability variables include adverse events (AEs), vital signs, physical examination,
standard 12 lead electrocardiogram (ECG) intervals, and clinical laboratory results.
The study will consist of a Screening Period of up to 20 days (Days -21 to -2) and a Study
Period of 15 days. Therefore, the maximum duration of participation from Screening until
discharge from the clinic for a subject is 35 days.
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