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NCT05368935 · ClinicalTrials.gov registry record · Phase 1

Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

A Phase 1 study, sponsored by Genfit.

Completed
Registry status
Phase 1
Development phase
77
Enrollment target

NCT05368935: Completed Phase 1 study, sponsored by Genfit.

NCT05368935 is a Phase 1 study that has completed, run by Genfit. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05368935, a Phase 1 study, has completed, sponsored by Genfit.

COMPLETED
Registry status
Phase 1
Development phase
77 participants
Enrollment target

Study Summary

This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with renal impairment and healthy adults.

Primary Outcome

Plasma pharmacokinetic (PK) parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers

Interventions

  • DRUG Nitazoxanide

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2022-04-25
Est. Completion 2022-09-09
Phase Phase 1
Genfit

11 total trials

What the finished NCT05368935 record still lists

NCT05368935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).

The record links to 0 conditions, and to 1 intervention - of which Nitazoxanide is the first listed.

NCT05368935 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05368935 about?

NCT05368935 is a clinical study titled "Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects". This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with renal impairment and healthy adults.

What is the current status of trial NCT05368935?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2022-04-25. Estimated completion is 2022-09-09.

What interventions are being tested in trial NCT05368935?

The interventions under investigation include: Nitazoxanide (DRUG).

Who is sponsoring clinical trial NCT05368935?

This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05368935's enrollment target sits among peer trials

77 703rd of 2000 higher than 1,296 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 NCT05368935, the US trial registry maintained by the National Library of Medicine. NCT05368935 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.