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

Zeria Pharmaceutical6 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Male Subjects

Interventions

14C-Z-215DRUG

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

Eligibility

Sex: MALEMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

UK, United Kingdom

Outcomes

Primary Outcomes

Mass balance recovery of total radioactivity concentration in plasma, red blood cells and whole blood

Time frame: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose

Concentration of Z-215 in plasma

Time frame: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose

Mass balance recovery of total radioactivity in urine

Time frame: Predose, 0 to 6, 6 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose)

Mass balance recovery of total radioactivity in faecal

Time frame: Predose, 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose)

Data from ClinicalTrials.gov

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