check_circleStudy Completed

Respiratory system

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years

Trial summary

Enrollment Goal
24
Trial Dates
April 2012 - July 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Inamed GmbHGauting, 82131, Germany

Primary Outcome

  • Ciprofloxacin pharmacokinetics including lung deposition
    Firstly, scintigraphic imaging, a non-invasive method using a radioactive (99mTc-) label tagged to the formulation, will be used to describe the distribution and deposition of a single inhaled dose of Ciprofloxacin Dry Powder Inhalation (DPI) in the lung quantitatively. Secondly, based on blood sampling over a period of 24 hours after inhalation non-compartmental pharmacokinetic parameters of ciprofloxacin will be calculated to determine the systemic exposure to drug following inhalation of a single 32.5 mg Ciprofloxacin dose.
    date_rangeTime Frame:
    Within 24 hours after treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Adverse Events collection
    date_rangeTime Frame:
    Within 30 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4