Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function

NCT ID: NCT00626249

Last Updated: 2013-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-10-31

Brief Summary

24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One screening, one dosing & one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points

Detailed Description

This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of Technosphere® Inhalation Powder as compared to kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics of the study medication. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of Technosphere® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .

Conditions

Mild Nephropathy; Moderate Nephropathy; Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

T Inhalation powder in diabetic subjs w/ normal renal func

T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units

Group Type: EXPERIMENTAL

Technosphere Inhalation Powder

Intervention Type: DRUG

Technosphere Inhalation Powder

T Inhalation powder diabetic subj w/mild or moderate nephrop

T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units

Group Type: EXPERIMENTAL

Technosphere Inhalation Powder

Intervention Type: DRUG

Technosphere Inhalation Powder

Interventions

Technosphere Inhalation Powder

Technosphere Inhalation Powder

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2
• Type 1 or type 2 diabetic
• Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria
• Normal pulmonary function and performance based on PFTs

Exclusion Criteria

• No history of COPD, asthma, or active respiratory infection; must be able to perform PFTs
• No dose and/or formulation changes within the preceding 6 weeks for any concomitant medications
• No clinically significant major organ/systemic disease
• No previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity
• No clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with DNP

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Boss

Role: STUDY_DIRECTOR

Mannkind Corporation

Locations

Davita Clinical Research

Minneapolis, Minnesota, United States

Qualia Clinical Research

Omaha, Nebraska, United States

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Countries

United States

Other Identifiers

MKC-T-017

Identifier Type: -

Identifier Source: org_study_id