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

NCT01982604 | Completed Phase 1

• 1 other identifier: MKC-TI-179
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• GIR (area-under-the-serum Glucose Infusion Rate)

  0 to 360

Study Arms (2)

Sequence (Group) 1

EXPERIMENTAL

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)

Drug: TI-Inhalation Powder A; Drug: TI-Inhalation Powder B

Sequence (Group) 2

EXPERIMENTAL

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)

Drug: TI-Inhalation Powder A; Drug: TI-Inhalation Powder B

Interventions

TI-Inhalation Powder A DRUG

Inhaled Insulin

Sequence (Group) 1; Sequence (Group) 2

TI-Inhalation Powder B DRUG

Inhaled Insulin

Sequence (Group) 1; Sequence (Group) 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Unknown Facility

Chula Vista, California, 91911, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

US (1)