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Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects

NCT04415645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-06-04

No results posted yet for this study

Summary

This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of \[14C\]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.

Conditions

  • Healthy Adult Male

Interventions

DRUG

[14C]-VVZ-149

A single IV infusion of radio-labeled VVZ-149

Sponsors & Collaborators

  • Vivozon, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2020-03-06
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415645 on ClinicalTrials.gov