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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Vivozon, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Total radioactivity (TRA) concentration equivalents in plasma
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
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
Arms & Interventions
VVZ-149 Injections
Intervention: [14C]-VVZ-149 (Drug)
Outcomes
Primary Outcomes
Total radioactivity (TRA) concentration equivalents in plasma
Time Frame: Day 15
TRA concentration equivalents in urine
Time Frame: Day 15
TRA concentration equivalents in feces
Time Frame: Day 15
Drug concentrations in plasma
Time Frame: Hour 48
Mass balance
Time Frame: Day 15
Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose
Secondary Outcomes
- Treatment-emergent adverse events(Day 15)