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

NCT ID: NCT01982604

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-08-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence (Group) 1

Subjects randomized to Sequence 1 will receive TI in the following sequence:

TI-Inhalation Powder A TI-Inhalation Powder B

*30 units (10 units + 20 units)

Group Type: EXPERIMENTAL

TI-Inhalation Powder A

Intervention Type: DRUG

Inhaled Insulin

TI-Inhalation Powder B

Intervention Type: DRUG

Inhaled Insulin

Sequence (Group) 2

Subjects randomized to Sequence 2 will receive TI in the following sequence:

TI-Inhalation Powder B TI-Inhalation Powder A

*30 units (10 units + 20 units)

Group Type: EXPERIMENTAL

TI-Inhalation Powder A

Intervention Type: DRUG

Inhaled Insulin

TI-Inhalation Powder B

Intervention Type: DRUG

Inhaled Insulin

Interventions

TI-Inhalation Powder A

Inhaled Insulin

Intervention Type: DRUG

TI-Inhalation Powder B

Inhaled Insulin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chula Vista, California, United States

Countries

United States

Other Identifiers

MKC-TI-179

Identifier Type: -

Identifier Source: org_study_id