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

Phase 1

Completed

• Conditions: Healthy Adult Male
• Interventions: Drug: [14C]-VVZ-149

• Registration Number: NCT04415645
• Lead Sponsor: Vivozon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-24
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VVZ-149 Injections	[14C]-VVZ-149	-

Primary Outcome Measures

Name	Time	Method
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
Mass balance	Day 15	Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	Day 15

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States