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

Study Overview
=================
Brief Summary
-----------------
24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One screening, one dosing & one follow-up visit with TechnosphereÂ® Inhalation Powder given at Visit 2 via MedToneÂ® 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 TechnosphereÂ® 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 TechnosphereÂ® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .

Official Title
-----------------
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

Conditions
-----------------
Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Technosphere Inhalation Powder


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention 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<br>T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units | Drug: Technosphere Inhalation Powder<br>* Technosphere Inhalation Powder<br>|
| Experimental: T Inhalation powder diabetic subj w/mild or moderate nephrop<br>T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units | Drug: Technosphere Inhalation Powder<br>* Technosphere Inhalation Powder<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in exposure to fumaryl diketopiperazine (FDKP) |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional safety parameters |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nephropathy, Kidney Disease, Diabetic, Renal, Diabetics