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
Overview
- Phase
- Phase 1
- Intervention
- Technosphere Inhalation Powder
- Conditions
- Mild Nephropathy
- Sponsor
- Mannkind Corporation
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Differences in exposure to fumaryl diketopiperazine (FDKP)
- Status
- Completed
- Last Updated
- 12 years ago
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 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 .
Investigators
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
Arms & Interventions
T Inhalation powder in diabetic subjs w/ normal renal func
T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
Intervention: 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
Intervention: Technosphere Inhalation Powder
Outcomes
Primary Outcomes
Differences in exposure to fumaryl diketopiperazine (FDKP)
Time Frame: 14 days
Secondary Outcomes
- Additional safety parameters(14 days)