A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC 0-∞
研究概览
简要总结
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
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
- Triple (Participant, Care Provider, 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
- •Informed Consent Form (ICF) prior to any study related procedures
- •Male and female first generation Japanese subjects 18 to 45 years, inclusive
- •Good general health
- •Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
- •Clinical labs within normal ranges 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 neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- •History of ECG abnormalities
- •Cancer not in complete remission for at least 5 years
- •Clinically significant, symptomatic prostatic hypertrophy
- •Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
- •Clinically significant bladder neck obstruction or urinary retention
- •Inadequately treated glaucoma
- •History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
- •Subjects with pre-existing anemia and/or iron deficiency
研究组 & 干预措施
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
干预措施: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 (Drug)
Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
干预措施: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 (Drug)
Glycopyrronium (GP) Dose 1
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
干预措施: Glycopyrronium (GP) Dose 1 (Drug)
Glycopyrronium (GP) Dose 2
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
干预措施: Glycopyrronium (GP) Dose 2 (Drug)
结局指标
主要结局
AUC 0-∞
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
Vd/F
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Cmax
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
AUC 0-12
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
Tmax
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
CL/F
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
AUC 0-t
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
T 1/2
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
Lambda z
时间窗: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
次要结局
- Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose(12 Hours)
- Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose(12 hours)
- Change in Heart Rate From Pre-dose to 12 Hours Post Dose(12 hours)
- Change in PR Interval From Pre-dose to 12 Hours Post Dose(12 hours)
- Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose(12 hours)
- Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose(12 hours)
- Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose(12 hours)
- Change in QRS Axis From Pre-dose to 12 Hours Post Dose(12 hours)
- Change in QRS Duration From Pre-dose to 12 Hours Post Dose(12 hours)
- Change in QT Interval From Pre-dose to 12 Hours Post Dose(12 hours)