A single dose, 3-way cross-over study comparing the safety, tolerability and pharmacokinetics of two inhaled Liposomal Ciprofloxacin Hydrochloride (HCl) for Inhalation formulations in two different nebulizers in healthy adults, with single dose assessment in subjects with non-Cystic Fibrosis (CF) bronchiectasis.
- Conditions
- on-Cystic Fibrosis (CF) bronchiectasisNon-Cystic Fibrosis (CF) bronchiectasisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12609000544279
- Lead Sponsor
- Aradigm Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Healthy subjects must be:
- Between 18 and 55 years of age, inclusive
- Healthy subjects as confirmed by medical history, physical examination, vital sign
measurements, pulmonary function tests, ECG as well as blood and urine clinical
laboratory tests;
- Female subjects of child-bearing potential who are sexually active must be willing to
undergo a pregnancy test and agree to use two forms of contraception (e.g. a hormonal
contraception and barrier method contraception or alternatively, two barrier methods [for females not on a hormonal contraceptive]) from screening, for the duration of the study, and up to 30 days after the last dose of study treatment. To be considered not to be of child-bearing potential”, female subjects must be at least 2 years postmenopausal or have been irreversibly surgically sterilized (by hysterectomy, oophorectomy or bilateral
tubal ligation);
- Body Mass Index (BMI) between 18.5 and 30, inclusive
- Non-smokers for at least 6 months prior to screening (all types of tobacco including
cigars); if an ex-smoker, smoked less than 20 cigarettes (or equivalent) per day over a 10 year period
- Pulmonary function tests within normal limits at screening (= 80% of predicted);
- Good venous access in both arms to allow collection of numerous blood samples;
- Demonstrated ability to take inhaled medications via nebulizer after appropriate training following admission on Rhesus Theta-Defensin-1 (RTD-1)
- Fluent in the English language (written and spoken)
- Provided written informed consent to participate in the study and are willing to comply with all study procedures
Subjects with non-CF bronchiectasis must be:
- Male and female subjects age 18 - 80 years, inclusive
- Confirmed diagnosis of non-CF bronchiectasis per High Resolution Computed Tomography (HRCT) within 3 years of screening
- FEV1 at screening at least 40%, and not greater than 90% of predicted values. FEV1
must also be 1 liter or greater in absolute volume measure
- A history of positive Pseudomonas Aeruginosa (P. aeroginosa) in a sputum/deep-throat cough swab culture or
brochoalveolar lavage [BAL]) within 6 months prior to screening
- Clinically stable and
able to enter the study in the opinion of the investigator
- Female subjects of child-bearing potential who are sexually active must be willing to
undergo a pregnancy test and agree to use two forms of contraception (e.g. a
hormonal contraception and barrier method contraception or alternatively, two barrier
methods [for females not on a hormonal contraceptive]) from screening, for the
duration of the study, and up to 30 days after the last dose of study treatment. To be
considered not of child-bearing potential”, female subjects must be at least 2 years
postmenopausal, or have been irreversibly surgically sterilized (by hysterectomy,
oophorectomy, or bilateral tubal ligation).
- Non-smokers for at least 6 months prior to screening (all types of tobacco including
cigars)
- Good venous access in both arms to allow collection of numerous blood samples;
- Fluent in the English language (written and spoken);
- Provide written informed consent to participate in the study and be willing to comply with all study procedures.
Healthy subjects must not have any of the following:
- Participation in another clinical trial within 30 days of screening visit or receipt of an
experimental therapy within 30 days prior to dosing
- Donation >450 ml of blood within 8 weeks of first treatment dose
- Recent (1 year) history of drug or alcohol dependence
- Positive screening test for Human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C
antibody
- Known or suspected local or systemic hypersensitivity to quinolone antibiotics or
tobramycin
- Viral illness within the last 30 days prior to screening
- Evidence of clinically relevant oral, cardiovascular, hematologic,gastrointestinal,
hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
- Pregnant or breast-feeding
- Males who are sexually active and of reproductive potential and whose female
partners are of child-bearing potential (definition as above) who are not prepared to used adequate birth control, defined as a condom plus spermicidal gel or foam from
screening, for the duration of the study, and up to 30 days after the last dose of
study treatment. Surgical sterilization must be documented in the medical file.
- Use of any ciprofloxacin or related drugs prior to the recruitment interview, such that
these drugs will have been ingested in the 4 weeks prior to the first dosing day
- Use of any other prescription medication (except oral contraceptives) during the 7
days prior to study dosing unless approved by both the Principal Investigator and the
sponsor
- Use of any over the counter product, herbal product, diet aid, hormone supplement, etc., within 7 days of study dosing unless approved by both the Principal Investigator and the sponsor
- Greater than normal alcohol consumption (i.e. more than 21 standard drinks per
week for males, or more than 14 standard drinks per week for females)
- Ingestion of any poppy seeds within the 48 hours prior to the screening blood test
(subjects will be advised by phone not to consume any poppy seed in this time
period)
- Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines
(i.e. tea, coffee, caffeine or cola drinks or chocolate) or grapefruit-containing foods or
beverages within the 24 hours prior to, or any of the above within the first 24 hours
after dosing
- Positive urine cotinine result at screening or at admission to clinic (details in
Appendix 1)
- Positive breath alcohol result at screening or at admission to clinic (details in
Appendix 1)
- Detection of any drug listed Appendix 1 (point 4a) in the urine drug screen at
recruitment or any drug listed in Appendix 1 (point 4b) in the urine drug screen at
admission, unless there is an explanation acceptable to the medical investigator (e.g.
the subject has stated in advance that they consumed a prescription product which
contained the detected drug) and/or the subject has a negative urine drug screen on
retest by the pathology laboratory
- Failure to conform to the requirements of the protocol
- Vital signs outside the reference range and clinically significant
- Any clinically significant biochemical or hematological abnormality or any clinically
significant abnormality in the urinalysis result
- Any vigorous exercise or strenuous activity within at least 48 hours before admission
Subjects are requested to refrain as much as possible, from taking co
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method