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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: [14C]-VVZ-149

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Key Inclusion Criteria:

• Healthy, adult, male, 19-55 years of age, inclusive
• Continuous non-smoker
• BMI ≥ 18.0 and ≤ 32.0 kg/m2
• Medically healthy with no clinically significant medical history or findings
• Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

• History or presence of clinically significant medical or psychiatric condition or disease
• History or presence of alcohol or drug abuse within the past 2 years
• History, presence or evidence of cardiovascular, renal or hepatic impairment
• Less or abnormal bowel movements
• Unable to refrain from or anticipates the use of any prohibited drugs
• Recent donation of blood/plasma or significant blood loss
• Radiation exposure within 12 months
• Participation in another clinical study within 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VVZ-149 Injections	Drug: [14C]-VVZ-149; A single IV infusion of radio-labeled VVZ-149

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass balance	Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose	Day 15
Total radioactivity (TRA) concentration equivalents in plasma		Day 15
TRA concentration equivalents in urine		Day 15
TRA concentration equivalents in feces		Day 15
Drug concentrations in plasma		Hour 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse events	Day 15

Collaborators and Investigators

• Sponsor: Vivozon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: VVZ149-HMB-P1-US101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No