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).

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: 14C-Z-215

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • UK, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14C-Z-215	Drug: 14C-Z-215; Single oral dose of 20mg Z-215 and 14C-Z-215 solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mass balance recovery of total radioactivity concentration in plasma, red blood cells and whole blood	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	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	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	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)

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 27, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Z215-03