Pharmacokinetic Study in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Technosphere® Insulin Inhalation Powder
* Drug: Technosphere® Insulin Inhalation Powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: Technosphere® Insulin Inhalation Powder<br>* 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)<br>* Other names: Inhaled human insulin and Technosphere Powder;|
| Experimental: Cohort 2<br> | Drug: Technosphere® Insulin Inhalation Powder<br>* 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)])<br>* Other names: Inhaled human insulin and Technosphere Powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered |  | 0-120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by adverse events |  | 32 days | 
| Safety will be assessed by Spirometry (FEV1) |  | 32 Days | 
| Safety will be assessed by vital sign measurements |  | 32 Days | 
| Safety will be assessed by physical examination findings. |  | 32 Days | 
| Safety will be assessed by clinical laboratory test results. |  | 32 Days |