Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers

Study Overview
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Brief Summary
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A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.

Official Title
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A Phase 1, Open-label, Randomized, Crossover Clinical Trial to Evaluate PK/PD of 30 U TI Inhalation Powders Prepared With Insulin From Two Different Suppliers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: TI-Inhalation Powder A
* Drug: TI-Inhalation Powder B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis HNVs with a screening blood pressure less than 140/90 mm Hg Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL Good venous access for blood draws No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing < 100 ng/mL Body mass index (BMI) < 32 kg/m2 Completion of informed consent form Exclusion Criteria: Blood donation (500 mL) within the last 8 weeks Fasting blood sugar >100 mg/dL History of coronary artery disease, peripheral vascular disease, or congestive heart failure Allergy to study drug, components of Boost and Boost Plus, or other study material Clinically significant active or chronic illness History of asthma, COPD, or any other clinically relevant chronic lung disease Respiratory tract infection within 4 weeks before screening History of drug or alcohol abuse within the past 5 years Positive urine drug screen Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism History of malignancy within the 5 years before screening (other than basal cell carcinoma) History of human immunodeficiency virus (HIV) infection or hepatitis B or C Women who are pregnant, lactating, or planning to become pregnant during the clinical study period Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile. Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Sequence (Group) 1<br>Subjects randomized to Sequence 1 will receive TI in the following sequence: TI-Inhalation Powder A TI-Inhalation Powder B *30 units (10 units + 20 units) | Drug: TI-Inhalation Powder A<br>* Inhaled Insulin<br>Drug: TI-Inhalation Powder B<br>* Inhaled Insulin<br>|
| Experimental: Sequence (Group) 2<br>Subjects randomized to Sequence 2 will receive TI in the following sequence: TI-Inhalation Powder B TI-Inhalation Powder A *30 units (10 units + 20 units) | Drug: TI-Inhalation Powder A<br>* Inhaled Insulin<br>Drug: TI-Inhalation Powder B<br>* Inhaled Insulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes |  | 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240 | 
| Cmax (maximum serum insulin concentration) |  | 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GIR (area-under-the-serum Glucose Infusion Rate) |  | 0 to 360 |