ACTRN12609000544279已完成1 期
A single dose, 3-way cross-over study comparing the safety, tolerability and pharmacokinetics of two inhaled Liposomal Ciprofloxacin Hydochloride (HCl) for Inhalation formulations in two different nebulizers in healthy adults, with single dose assessment in subjects with non-Cystic Fibrosis (CF) bronchiectasis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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
- •- 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.
排除标准
- •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
- •- Known or suspected local or systemic hypersensitivity to quinolone antibiotics or
- •- 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
- •- 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
- •- 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
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