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

A Phase I Mass Balance and Metabolism Study of 14C-Z-215 in Healthy Male Volunteers

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).

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.