A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) - Formoterol
研究概览
简要总结
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
详细描述
A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male and female Chinese subjects 18-45 years of age
- •Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.
- •A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception
- •Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.
排除标准
- •Pregnant or nursing female subjects or subjects who are trying to conceive
- •Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- •Subjects with a history of ECG abnormalities
- •Subjects who have cancer that has not been in complete remission for at least 5 years
- •Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
- •Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
- •Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
- •Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated
- •History of substance-related disorders within 1 year of Screening
- •History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting
- •A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period
- •Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days
- •Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening
- •Positive for Syphilis Antibody
- •Subjects with any flu-like syndrome or other respiratory infections
- •Recently vaccinated with an attenuated live virus
研究组 & 干预措施
PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
干预措施: PT010 (BGF MDI) 320/14.4/9.6 µg (Drug)
PT010 (BGF MDI) 160/14.4/9.6 µg
PT010 (BGF MDI) 160/14.4/9.6 µg
干预措施: PT010 (BGF MDI) 160/14.4/9.6 µg (Drug)
PT003 (GFF MDI) 14.4/9.6 µg
PT003 (GFF MDI) 14.4/9.6 µg
干预措施: PT003 (GFF MDI) 14.4/9.6 µg (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) - Formoterol
时间窗: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Formoterol Day 8
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium
时间窗: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium
时间窗: Day 1
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol
时间窗: Day 1
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
时间窗: Day 8
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide
时间窗: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
时间窗: Day 8
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol
时间窗: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Apparent Total Body Clearance (CL/F) - Glycopyrronium
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent total body clearance (CL/F) - Glycopyrronium Day 1
Apparent Volume of Distribution (Vd/F) - Formoterol
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent volume of distribution (Vd/F) - Formoterol - Day 1
Terminal Elimination Rate Constant (λz) - Budesonide
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal elimination rate constant (λz) - Budesonide - Day 1
Maximum Plasma Concentration (Cmax) - Budesonide
时间窗: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Budesonide Day 8
Maximum Plasma Concentration (Cmax) - Glycopyrronium
时间窗: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
时间窗: Day 8
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
Time to Maximum Plasma Concentration (Tmax) - Budesonide
时间窗: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Budesonide Day 8
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
时间窗: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide
时间窗: Day 1
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
Time to Maximum Plasma Concentration (Tmax) - Formoterol
时间窗: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Formoterol Day 8
Elimination Half-life (t½) - Budesonide
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination half-life (t½) - Budesonide Day 1
Elimination Half-life (t½) - Glycopyrronium
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination half-life (t½) - Glycopyrronium Day 1
Apparent Total Body Clearance (CL/F) - Formoterol
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent total body clearance (CL/F) - Formoterol Day 1
Apparent Volume of Distribution (Vd/F) - Budesonide
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent volume of distribution (Vd/F) - Budesonide - Day 1
Apparent Volume of Distribution (Vd/F) - Glycopyrronium
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
Elimination Half-life (t½) - Formoterol
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination half-life (t½) - Formoterol Day 1
Apparent Total Body Clearance (CL/F) - Budesonide
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent total body clearance (CL/F) - Budesonide Day 1
Terminal Elimination Rate Constant (λz) - Glycopyrronium
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
Terminal Elimination Rate Constant (λz) - Formoterol
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal elimination rate constant (λz) - Formoterol - Day 1
Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation ratio for Cmax (RAC \[Cmax\]) - Budesonide
Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium
时间窗: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation ratio for Cmax (RAC \[Cmax\]) - Glycopyrronium
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
时间窗: Day 1 and Day 8
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Budesonide
Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol
时间窗: Day 1 and Day 8
Accumulation ratio for Cmax (RAC \[Cmax\]) - Formoterol
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
时间窗: Day 1 and Day 8
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Glycopyrronium
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
时间窗: Day 1 and Day 8
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Formoterol
次要结局
- Electrocardiogram(Visit 4, Day 8)
- Physical Exam Findings(Visit 4, Day 8)
- Serious Adverse Events/Adverse Events(Visit 4, Day 8)
- Vital Signs(Visit 4, Day 8)
- Laboratory Tests(Visit 4, Day 8)