Pharmacokinetic Study in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365117
• Other study ID #: MKC-TI-167
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2011
• Last updated: June 12, 2012
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy

• Body mass index (BMI) < 32 kg/m2

• FEV1 = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria:

• Pre-existing asthma or chronic obstructive pulmonary disease (COPD)

• History of coronary artery disease, peripheral vascular disease, or congestive heart failure

• Blood donation within the previous 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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)
• 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)])

Locations

Country	Name	City	State
United States	Celerion	Neptune	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered		0-120 minutes	No
Secondary	Safety will be assessed by adverse events		32 days	Yes
Secondary	Safety will be assessed by Spirometry (FEV1)		32 Days	Yes
Secondary	Safety will be assessed by vital sign measurements		32 Days	Yes
Secondary	Safety will be assessed by physical examination findings.		32 Days	Yes
Secondary	Safety will be assessed by clinical laboratory test results.		32 Days	Yes