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NCT04415645 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Vivozon.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT04415645: Completed Phase 1 study, sponsored by Vivozon.

NCT04415645 is a Phase 1 study that has completed, run by Vivozon. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04415645, a Phase 1 study, has completed, sponsored by Vivozon.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study 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.

Primary Outcome

Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose

Interventions

  • DRUG [14C]-VVZ-149

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2020-02-24
Est. Completion 2020-03-31
Phase Phase 1
Vivozon

5 total trials

What the finished NCT04415645 record still lists

NCT04415645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which [14C]-VVZ-149 is the first listed.

NCT04415645 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04415645 about?

NCT04415645 is a clinical study titled "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 meas...

What is the current status of trial NCT04415645?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-02-24. Estimated completion is 2020-03-31.

What interventions are being tested in trial NCT04415645?

The interventions under investigation include: [14C]-VVZ-149 (DRUG).

Who is sponsoring clinical trial NCT04415645?

This trial is sponsored by Vivozon, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04415645's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04415645, the US trial registry maintained by the National Library of Medicine. NCT04415645 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.