Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGTI-Inhalation Powder A
Inhaled Insulin
DRUGTI-Inhalation Powder B
Inhaled Insulin
Sponsors
Mannkind Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| GIR (area-under-the-serum Glucose Infusion Rate) | 0 to 360 |
Countries
United States
Outcome results
None listed