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OpenTrials
Completed

NCT Number: NCT04415645

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

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.

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Key information

Conditions

Healthy Adult Male

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]-VVZ-149

Drug

A single IV infusion of radio-labeled VVZ-149

Primary outcomes

  1. 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

  2. Total radioactivity (TRA) concentration equivalents in plasma

    Time frame: Day 15

  3. TRA concentration equivalents in urine

    Time frame: Day 15

  4. TRA concentration equivalents in feces

    Time frame: Day 15

  5. Drug concentrations in plasma

    Time frame: Hour 48

Secondary outcomes

  1. Treatment-emergent adverse events

    Time frame: Day 15

Sponsors and collaborators

Lead sponsor

Vivozon, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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