NCT01538667

Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases

Non-blinded, Single Dose, Single Centre Trial to Assess the Pulmonary Deposition as Well as Pharmacokinetics, Safety and Tolerability of 99mTc Labeled Ciprofloxacin When Delivered as a Single Dose From a Dry Powder Inhaler to Healthy Subjects With and Without Charcoal Block and Patients Suffering From Bronchiectasis and COPD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize variability and extent of the deposition of ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be evaluated. In this study the radiolabeled substance will be administered and scintigraphy imaging techniques will be used to demonstrate the lung deposition visually. In the healthy subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block). Safety investigations will focus on local tolerability in the lung. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to show how the drug is distributed in the human lung.

Conditions

• Respiratory System

Interventions

Type	Name	Description
DRUG	Ciprofloxacin (Cipro Inhale, BAYQ3939)	50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects
DRUG	Ciprofloxacin (Cipro Inhale, BAYQ3939)	50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block
DRUG	Ciprofloxacin (Cipro Inhale, BAYQ3939)	50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients
DRUG	Ciprofloxacin (Cipro Inhale, BAYQ3939)	50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-02-24
• Last updated: 2014-08-21

Locations

1 site across 1 country: Germany