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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02618629

Enrollment

Registered

2015-12-01

Start date

2016-01-31

Completion date

2016-09-30

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

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).

Interventions

DRUG14C-Z-215

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026