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NCT01841996 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

A Phase 1 study of Onychomycosis, sponsored by Meiji Seika Pharma Co..

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
2
Study locations

NCT01841996: Completed Phase 1 study of Onychomycosis, sponsored by Meiji Seika Pharma Co..

NCT01841996 is a Phase 1 study of Onychomycosis that has completed, run by Meiji Seika Pharma Co.. The registered enrollment target is 24 participants, below the 92-participant average among 11 other Onychomycosis trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01841996, a Phase 1 study of Onychomycosis, has completed, sponsored by Meiji Seika Pharma Co..

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
2
Study locations

Study Summary

This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study. The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the toenails.

Conditions Studied

Interventions

  • DRUG Vehicle Solution
  • DRUG ME1111 solution

Study Locations (2)

Texas

  • - Austin
  • - College Station

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2013-03
Phase Phase 1
Meiji Seika Pharma Co.

5 total trials

What the finished NCT01841996 record still lists

NCT01841996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 92-participant average among 11 other Onychomycosis trials with a reported enrollment target (74% lower).

The record links to 1 condition, with Onychomycosis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle Solution is the first listed.

NCT01841996 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01841996 about?

NCT01841996 is a clinical study titled "Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients". This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study. The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychom...

What is the current status of trial NCT01841996?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-03.

What conditions does trial NCT01841996 study?

This clinical trial studies the following conditions: Onychomycosis.

What interventions are being tested in trial NCT01841996?

The interventions under investigation include: Vehicle Solution (DRUG), ME1111 solution (DRUG).

Who is sponsoring clinical trial NCT01841996?

This trial is sponsored by Meiji Seika Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01841996 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Onychomycosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01841996's enrollment target sits among peer trials

24 11th of 11 higher than 1 of 11 other Onychomycosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Onychomycosis 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 NCT01841996, the US trial registry maintained by the National Library of Medicine. NCT01841996 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.