A Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Overall safety of BGF, GFF, and Symbicort MDI based on the group of outcome measures for safety.
研究概览
简要总结
This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to budesonide following administration of Symbicort MDI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide signed written informed consent form
- •18 and 45 years (inclusive)
- •Healthy subject confirmed by a thorough medical history and physical examination, ECG, vital signs and clinical laboratory tests
- •Females of childbearing potential and males with female partners of childbearing potential must agree to use medically acceptable contraception
- •Body mass index (BMI) between 18.5 and 32 kg/m2 (inclusive) and a minimum weight of 50 kg at the screening visit
- •Results of complete laboratory analyses should be within the normal range or determined to be not clinically significant by the Investigator
排除标准
- •Pregnancy, nursing female subjects, or subjects trying to conceive
- •Clinically significant medical conditions
- •History of ECG abnormalities
- •Symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
- •Known diagnosis of glaucoma
- •Known or suspected history of substance-related disorders within 1 year of screening
- •Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening period
- •Hypersensitivity to lactose or any drug or component of the formulation(s) used in this study
- •Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at screening.
- •Major surgery within four weeks or minor surgery within 2 weeks of drug administration
- •Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for study participation
研究组 & 干预措施
GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 2 (Drug)
BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 2 (Drug)
BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 2 (Drug)
BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 1 (Drug)
BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 3 (Drug)
BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
干预措施: Inhaled GFF (PT003) (Drug)
BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 1 (Drug)
BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 3 (Drug)
BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled GFF (PT003) (Drug)
BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 1 (Drug)
BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 2 (Drug)
BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 1 (Drug)
BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 2 (Drug)
BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
干预措施: Inhaled GFF (PT003) (Drug)
BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 1 (Drug)
BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 2 (Drug)
GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 1 (Drug)
GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 3 (Drug)
GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 1 (Drug)
GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 2 (Drug)
Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 1 (Drug)
Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 2 (Drug)
Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 3 (Drug)
Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
干预措施: Inhaled GFF (PT003) (Drug)
Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 2 (Drug)
Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 1 (Drug)
Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 2 (Drug)
Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled BGF (PT010) Dose 3 (Drug)
Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled GFF (PT003) (Drug)
Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
干预措施: Inhaled Symbicort Dose 1 (Drug)
结局指标
主要结局
Overall safety of BGF, GFF, and Symbicort MDI based on the group of outcome measures for safety.
时间窗: 12 hours following study drug administration
Safety of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort Inhalation Aerosol. The safety of BGF MDI, Symbicort MDI and GFF MDI will be assessed from physical examination findings, adverse event (AE) reporting including SAE reporting, vital signs (blood pressure, heart rate, respiratory rate and body temperature), clinical laboratory values (hematology, biochemistry, and urinalysis), and findings from 12-lead safety electrocardiograms (ECGs).
次要结局
- Overall pharmacokinetic profile of BGF, GFF, and Symbicort MDI based on the group of outcome measures for pharmacokinetics.(12 hours following study drug administration)