NCT01490762

Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler

A Phase 1, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Effect Following Inhalation of Technosphere® Insulin Inhalation Powder at Multiple Doses Using the Gen2C Inhaler

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.

Detailed description

Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to determine the insulin dose proportionality/linearity of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of the following doses using the Gen2C inhaler: * 10 U (one 10 U cartridge) * 30 U (one 10 U and one 20 U cartridge) * 60 U (three 20 U cartridges) * 80 U (four 20 U cartridges)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Technosphere Insulin Inhalation Powder using the Gen2C inhaler	Inhalation Powder
DRUG	Regular Human Insulin	Subcutaneous injection

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2011-12-13
• Last updated: 2012-09-07

Locations

1 site across 1 country: United States