Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982604
• Other study ID #: MKC-TI-179
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2013
• Last updated: October 1, 2014
• Start date: November 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TI-Inhalation Powder A
Inhaled Insulin
• TI-Inhalation Powder B
Inhaled Insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Cmax (maximum serum insulin concentration)		5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240	No
Secondary	GIR (area-under-the-serum Glucose Infusion Rate)		0 to 360	No