ACTRN12617001501336已完成1 期
A Phase 1 Study of AP01 (Aerodone™, Pirfenidone Solution for Inhalation) Delivered via the PARI eFlow® Nebulizer System in Healthy Volunteers, Smokers or Former Smokers with Decreased Lung Function, and Patients with Idiopathic Pulmonary Fibrosis (IPF) to determine pharmacokinetics, as well as the safety and tolerability in volunteers with a history of smoking with decreased lung function and IPF patients.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1.Males or females 18 to 55 years
- •2.Female subjects must be:
- •of non child-bearing potential [surgically sterilised or post–menopausal (12 months with no menses without alternative medical cause)] OR
- •not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 30 days after the last Investigational Medicinal Product (IMP) administration.
- •3.Must be able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form.Additional Inclusion Criterion for Cohort 5
- •4.Current or past smokers with > 20 pack year history of smoking and decreased lung function (FEV1 >= 50% predicted)
- •Additional Inclusion Criteria for Cohort 6
- •5.Diagnosis of IPF by American Thoracic Society (ATS) 2011 criteria
- •6.Males or females 18 to 70 years
- •7.For at least 2 subjects, > 20 pack year history of smoking
排除标准
- •1.History of previous allergy or sensitivity to pirfenidone.
- •2.Use of oral pirfenidone within 2 days prior to admission to Phase 1 facility.
- •3.History of reactive airways disease (such as asthma or chronic obstructive pulmonary disease (COPD), cystic fibrosis, or bronchiectasis (Cohorts 1-4 only). Cohort 5 will exclude cystic fibrosis and bronchiectasis but will allow a history of COPD and Asthma.
- •4.Human Immunodeficiency Virus Positive Result (HIV+).
- •5.Active Hepatitis B or C.
- •6.Cigarette/e-Cigarette smoking or use of other nicotine or tobacco containing products within seven days prior to study drug administration (Cohorts 1-4 only).
- •7.Positive for drugs of abuse or alcohol use at screening or admission to Phase 1 facility. A breathalyzer test will be used to screen for the presence of alcohol. A urine standard panel will be used to test for the following substances (with repeat testing for confirmation, as needed) (Cohorts 1-5 only):
- •Methadone
- •Tetrahydrocannabinol
- •Benzodiazepines
- •Amphetamines / Methamphetamines
- •Barbiturates
- •3,4-methylenedioxy-methamphetamine
- •Phencyclidine
- •8.Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives (T1/2) of the previously administered investigational product.
- •9.Donation of blood or significant blood loss within the 8 weeks prior to admission to Phase 1 facility.
- •10.Donation of plasma within the week prior to admission to Phase 1 facility.
- •11.Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- •12.Pregnant or nursing.
- •13.Use of any medication in the opinion of the Principal Investigator that that might interact with study medication or may lead to abnormal chemistry of hematology tests.
- •14.Clinically significant abnormality in the opinion of the Principal Investigator in baseline hematology or chemistry tests.
研究者
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