Status:
COMPLETED
Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler
Lead Sponsor:
Mannkind Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Ins...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01490762
Start Date
December 1 2011
End Date
July 1 2012
Last Update
September 7 2012
Active Locations (1)
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1
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911