Clinical trial NCT01982604: Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes
timeFrame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
measure: Cmax (maximum serum insulin concentration)
timeFrame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
Secondary outcomes:
measure: GIR (area-under-the-serum Glucose Infusion Rate)
timeFrame: 0 to 360
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
Study officials:
References: