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

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618629
• Other study ID #: Z215-03
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2015
• Last updated: September 21, 2016
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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)	No
Primary	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)	No