Mass Balance and Metabolism Study of 14C-Z-215

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).

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Detailed Description

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Conditions

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Healthy Male Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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14C-Z-215

Group Type EXPERIMENTAL

14C-Z-215

Intervention Type DRUG

Single oral dose of 20mg Z-215 and 14C-Z-215 solution

Interventions

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14C-Z-215

Single oral dose of 20mg Z-215 and 14C-Z-215 solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Any race/ethnic origin
* Subjects will have a body mass index (BMI) between 18.5 and 30.0 kg/m2
* Subjects will have a body weight between 50 and 110 kg
* Subjects will have given their written informed consent to participate in the study, and to abide by the study restrictions.

Exclusion Criteria

* Subjects who have a significant history of drug allergy, as determined by the Investigator.
* Subjects who have serum hepatitis or are carriers of the hepatitis B surface antigen (HBsAg) or the hepatitis C antibody.
* Subjects who have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
* Subjects who are exposed to radiation as a result of their occupation.
* Subjects who, in the opinion of the Investigator, should not participate in this study.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes