Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

NCT00426920 | Unknown Phase 1

• 1 other identifier: IOV/QD001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Conditions

Diabetes Mellitus

Keywords

pharmacokinetics; pharmacodynamics; inhaled; recombinant human insulin

Outcome Measures

Primary Outcomes (5)

• maximum insulin serum concentration

• early T50%

• late T50%

• Tmax

• AUC

Secondary Outcomes (5)

• maximum glucose infusion rate

• early T50%

• late T50%

• Tmax

• AUC

Interventions

Insulin DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male
• non smoking for at least 12 months
• BMI equal to or less than 28
• no clinically significant abnormalities
• FVC and FEV1 equal to or more than 80%
• willing to participate and to sign informed consent form

You may not qualify if:

• positive results for insulin antibodies at screening
• history of substance abuse or dependency within last 5 years
• positive screening test for substance abuse
• positive blood test for HIV, hepatitis B or hepatitis C antibody
• fasting blood glucose of more than 126mg/dl
• any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication
• history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality
• has received investigational medications within 21 days prior to receiving the first dose of study medication
• has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication
• has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication
• health that may be adversely affected by procedures or medications used in the study
• unwillingness or inability to understand or to follow required study restrictions and procedures

Sponsors & Collaborators

• QDose Limited: lead

Study Sites (1)

Profil Institute for Clinical Research Incorporated

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Respiratory Aspiration

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marcus Hompesch, MD

  Profil Institute for Clinical Research Incorporated

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Hompesch, MD

CONTACT

619-427-1300

24-hour emergency number

CONTACT

619-409-1277

Study Design

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

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 25, 2007
• Study Start: February 1, 2007
• Last Updated: January 25, 2007

Record last verified: 2007-01

Locations

US (1)