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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis

• Good venous access for blood draws

• No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negative urine cotinine testing (< 100 ng/mL)

• Body mass index (BMI) < 32 kg/m2

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

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

• Written informed consent provided

Exclusion Criteria:

• Blood donation of 500 mL within the previous 56 days

• Fasting blood sugar >130 mg/dL

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

• Allergy to study drug, food, or other study material (eg, peanuts, soy products)

• 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

• Donation of blood within 3 months before screening

• History of drug or alcohol abuse

• Positive urine drug screen

• Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality

• Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study

• 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 (except metformin

• 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

• Any subject who at Visit 2 has a blood glucose value = 150 mg/dL 2 hours after the meal, should be discussed with the MKC medical monitor and may be removed as potentially having impaired glucose tolerance

• Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder

• Women of childbearing potential (defined as premenopausal and not surgically sterilized 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