Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler

NCT01490762 | Completed Phase 1

• 1 other identifier: MKC-TI-176
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.

Conditions

Healthy

Keywords

PK; PD

Outcome Measures

Primary Outcomes (1)

• area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing

  crossover 4 times over the course of up to 5 weeks

Secondary Outcomes (3)

• Area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) compared to that of subcutaneous regular human insulin (RHI)

  crossover 5 times over the course of up to 6 weeks

• Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI

  crossover 5 times over the course of up to 6 weeks

• Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations

  crossover 5 times for up to 6 weeks

Study Arms (2)

Regular Human Insulin

ACTIVE COMPARATOR

Subcutaneous injection

Drug: Regular Human Insulin

TI and Regular Human Insulin

EXPERIMENTAL

All subjects have 4 clamp procedures with 10, 30, 60,80 units of TI and 1 clamp with 15 IU Regular Human Insulin

Drug: Technosphere Insulin Inhalation Powder using the Gen2C inhaler

Interventions

Technosphere Insulin Inhalation Powder using the Gen2C inhaler DRUG

Inhalation Powder

TI and Regular Human Insulin

Regular Human Insulin DRUG

Subcutaneous injection

Regular Human Insulin

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 who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
• Good venous access for blood draws
• No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negative urine cotinine testing (\< 100 ng/mL)
• Body mass index (BMI) \< 32 kg/m2
• FEV1 = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
• FVC = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
• Written informed consent provided

You may not qualify if:

• Blood donation of 500 mL within the previous 56 days
• Fasting blood sugar \>130 mg/dL
• History of coronary artery disease, peripheral vascular disease, or congestive heart failure
• Allergy to study drug, food, or other study material (eg, peanuts, soy products)
• 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
• Donation of blood within 3 months before screening
• History of drug or alcohol abuse
• Positive urine drug screen
• Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
• Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study
• 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 (except metformin
• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chief Medical Officer

  Mannkind Corporation

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 13, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)