NCT04415645

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

Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Vivozon, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	[14C]-VVZ-149	A single IV infusion of radio-labeled VVZ-149

Timeline

• Start date: 2020-02-24
• Primary completion: 2020-03-06
• Completion: 2020-03-31
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study