NCT02240290

Study to Evaluate the Absorption, Distribution, Break Down and Elimination and the Safety of 14C-Labeled Tozadenant

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• N/A, as Healthy Volunteers

Interventions

Type	Name	Description
DRUG	tozadenant tablet	Active substance: tozadenant Pharmaceutical form: Tablet Concentration: 240 mg Route of Administration: Oral administration
DRUG	C14-tozadenant capsule	Active substance: C14-tozadenant Pharmaceutical form: Capsule Concentration: 74 kBq (2 μCi) Route of administration: Oral administration

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2014-09-15
• Last updated: 2017-08-04

Locations

1 site across 1 country: Netherlands