NCT01365117

Pharmacokinetic Study in Healthy Volunteers

Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

Detailed description

Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin Inhalation Powder	15 subjects in a three-way crossover (three different doses of TI Inhalation Powder \[one 20 U, two 20 U and one 40 U cartridges)
DRUG	Technosphere® Insulin Inhalation Powder	16 subjects in a four-way crossover (four different doses of TI Inhalation Powder \[one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)\])

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2011-06-03
• Last updated: 2012-06-14

Locations

1 site across 1 country: United States