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

NCT04415645 | Completed Phase 1 FDA Drug

• 1 other identifier: VVZ149-HMB-P1-US101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Treatment-emergent adverse events

  Day 15

Study Arms (1)

VVZ-149 Injections

EXPERIMENTAL

Drug: [14C]-VVZ-149

Interventions

[14C]-VVZ-149 DRUG

A single IV infusion of radio-labeled VVZ-149

VVZ-149 Injections

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivozon, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: February 24, 2020
• Primary Completion: March 6, 2020
• Study Completion: March 31, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

US (1)