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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: TI-Inhalation Powder A; Drug: TI-Inhalation Powder B

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: TI-Inhalation Powder A; Inhaled Insulin; Drug: TI-Inhalation Powder B; Inhaled Insulin
Experimental: 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)	Drug: TI-Inhalation Powder A; Inhaled Insulin; Drug: TI-Inhalation Powder B; Inhaled Insulin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
GIR (area-under-the-serum Glucose Infusion Rate)	0 to 360

Collaborators and Investigators

• Sponsor: Mannkind Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): October 2, 2014
• Last Update Submitted That Met QC Criteria: October 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: MKC-TI-179