drugset / Trial / NCT00721344

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

NCT00721344 ↗

Phase 1 Completed 48 enrolled Mannkind Corporation
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2008-04
Primary completion
2008-08
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fumaryl Diketopiperazine Unknown 20 mg Inhaled
Subject Fumaryl Diketopiperazine Unknown 40 mg Inhaled
Subject Moxifloxacin Small molecule 400 mg Oral

Indications

No indication recorded.