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

Healthy Adult Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415645
• Other study ID #: VVZ149-HMB-P1-US101
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2020
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Vivozon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 31, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

Drug:
• [14C]-VVZ-149
A single IV infusion of radio-labeled VVZ-149

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Vivozon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance	Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose	Day 15
Primary	Total radioactivity (TRA) concentration equivalents in plasma		Day 15
Primary	TRA concentration equivalents in urine		Day 15
Primary	TRA concentration equivalents in feces		Day 15
Primary	Drug concentrations in plasma		Hour 48
Secondary	Treatment-emergent adverse events		Day 15