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

Mannkind Corporation36 enrolled

Overview

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

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 .

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Nephropathy Moderate Nephropathy Diabetes Mellitus

Interventions

Technosphere Inhalation PowderDRUG

Technosphere Inhalation Powder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Differences in exposure to fumaryl diketopiperazine (FDKP)

Time frame: 14 days

Secondary Outcomes

Additional safety parameters

Time frame: 14 days

Data from ClinicalTrials.gov

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