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

NCT02618629 | Completed Phase 1

• 1 other identifier: Z215-03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

14C-Z-215

EXPERIMENTAL

Drug: 14C-Z-215

Interventions

14C-Z-215 DRUG

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

14C-Z-215

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Unknown Facility

UK, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

GB (1)