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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04415645

Enrollment

Registered

2020-06-04

Start date

2020-02-24

Completion date

2020-03-31

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Male

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.

Interventions

DRUG[14C]-VVZ-149

A single IV infusion of radio-labeled VVZ-149

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Measure	Time frame
Treatment-emergent adverse events	Day 15

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026