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

MannKind

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Technosphere Insulin Inhalation Powder using the Gen2C inhaler

Drug: Regular Human Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01490762

MKC-TI-176

Details and patient eligibility

About

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.

Full 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 Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to determine the insulin dose proportionality/linearity of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of the following doses using the Gen2C inhaler:

10 U (one 10 U cartridge)
30 U (one 10 U and one 20 U cartridge)
60 U (three 20 U cartridges)
80 U (four 20 U cartridges)

Enrollment

35 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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