NCT00721344

A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.

A Phase 1, Randomized, Double-Blind, Cross-Over, Placebo- and Active-Controlled Cardiac Safety Study of Therapeutic and Supratherapeutic Doses of Fumaryl Diketopiperazine Administered as Technosphere® Inhalation Powder in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

48 healthy adult male \& female subjects will be enrolled in this study to determine the effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible subjects will be randomized into a dosing regimen after admission.

Detailed description

This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Technosphere Inhalation Powder (FDKP)	Technosphere® Inhalation Powder 20mg
DRUG	Moxifloxacin	Tablets 400mg
DRUG	Technosphere Inhalation Powder (FDKP)	Technosphere® Inhalation Powder 40mg
DRUG	Placebo	Placebo cartridges

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2008-07-24
• Last updated: 2012-06-13

Locations

1 site across 1 country: United States