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

NCT02240290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-08-04

No results posted yet for this study

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.

Conditions

  • N/A, as Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Tandem Labs

    collaborator UNKNOWN

  • Xceleron Inc

    collaborator UNKNOWN

  • Biotie Therapies Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02240290 on ClinicalTrials.gov