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

December 13, 2013 updated by: Mannkind Corporation

A Phase 1b, Single-Dose, Open Label, Parallel Design, Controlled Pharmacology Trial of Fumaryl Diketopiperazine Administered as Technosphere Inhalation Power in Subjects With Either Mild or Moderate Chronic Kidney Disease vs. Matched Subjects Without Chronic Kidney Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DaVita Clinical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68154
        • Qualia Clinical Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T Inhalation powder in diabetic subjs w/ normal renal func
T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
Drug: Technosphere Inhalation Powder
Technosphere Inhalation Powder
Experimental: 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
Drug: Technosphere Inhalation Powder
Technosphere Inhalation Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in exposure to fumaryl diketopiperazine (FDKP)
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional safety parameters
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mannkind Corporation

Investigators

  • Study Director: Anders Boss, Mannkind Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-T-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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