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

Zeria Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: 14C-Z-215

Study type

Interventional

Funder types

Industry

Identifiers

NCT02618629

Z215-03

Details and patient eligibility

About

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).

Enrollment

6 patients

Sex

Male

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.