NCT01014962

A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus

A Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Tolerability And Pharmacokinetic Study Of Escalating Doses Of Albaconazole In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.

Detailed description

This study aims to evaluate the safety and tolerability of 5 days of albaconazole dosing at levels that exceed both the projected therapeutic dose and the projected therapeutic frequency, in order to identify an upper dose for administration in a TQTc study. It also aims to assess the pharmacokinetics of multiple escalating doses of albaconazole, and to assess the effects of multiple and sustained dosing of high doses of albaconazole on ECG parameters.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Albaconozole	Albaconozole 400 mg oral once daily for 5 days
DRUG	Placebo	Placebo oral once daily for 5 days
DRUG	Albaconozole	Albaconozole 400 mg every 12 hours for 5 days
DRUG	Placebo	Placebo oral every 12 hours for 5 days
DRUG	Albaconozole	Albaconozole 400 mg oral every 8 hours for 5 days
DRUG	Placebo	Placebo oral every 8 hours for 5 days

Timeline

• Start date: 2009-08-24
• Primary completion: 2009-12-04
• Completion: 2009-12-04
• First posted: 2009-11-17
• Last updated: 2017-06-20

Locations

1 site across 1 country: United States