NCT00274313CompletedPhase 1
A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis
Parion Sciences30 sites in 1 country40 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 30
- Primary Endpoint
- Safety assessments
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients aged > 14 years.
- •Patients who are diagnosed with cystic fibrosis.
- •Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
- •Patients who are able to perform reproducible spirometry according to ATS guidelines.
- •Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.
Exclusion Criteria
- •Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
- •Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
- •Patients on angiotensin converting enzyme (ACE) inhibitors.
- •Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine > 2.0 mg/dL.
- •Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
- •Patients who are pregnant, have a positive pregnancy test, or are nursing.
- •Patients who have had a lung transplant.
Outcomes
Primary Outcomes
Safety assessments
Blood and urine laboratory tests
Pulmonary function tests
Electrocardiograms
Vital signs and pulse oximetry
Secondary Outcomes
- Plasma pharmacokinetics on Day 14 of the study.
Investigators
Study Sites (30)
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