A Randomized, Double-blind, Single Dose, Four-period, Four-treatment, Cross-over Study Evaluating the Safety of PT001, PT003, PT005 Administered Individually and PT001 + PT005 Delivered Together in Separate Inhalers in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Symptoms of Dry Mouth
研究概览
简要总结
The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide signed written informed consent
- •18-55 years of age
- •Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and 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
- •Body mass index (BMI) between 18.5 and 30, inclusive
- •Non-smokers for at least 6 months prior to screening
- •Pulmonary function tests within normal limits
- •Willing to remain at the study center for at least 12-24 hours on each test day
- •Venous access in both arms to allow collection of numerous blood samples
排除标准
- •Women who are pregnant or lactating
- •Clinically significant medical conditions
- •Viral illness within the last 30 days
- •Symptomatic prostatic hypertrophy or bladder neck obstruction
- •Known narrow-angle glaucoma
- •History of bowel obstruction
- •Clinically significant abnormal electrocardiogram
- •Positive Hepatitis B surface antigen or positive Hepatitis C antibody
- •Positive screening test for HIV antibodies
- •History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
- •Known or suspected history of alcohol or drug abuse within the last 2-years
- •Greater than normal alcohol consumption
- •Ingestion of any poppy seeds within the 48 hours prior to the screening
- •Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
- •Positive breath alcohol result
- •Positive urine drug screen
- •Use of any beta2-agonists,or anticholinergics prior to the recruitment interview
- •Lower respiratory tract infections requiring antibiotics in the previous 6 weeks
- •Use of any other prescription medication
- •Use of any over the counter product, herbal product, diet aid, hormone supplement
- •Donation > 450 ml of blood within 8 weeks of first treatment dose
- •Clinically significant vital sign abnormality
- •Clinically significant biochemical, hematological or urinalysis abnormality
- •Affiliations with investigator site
- •Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives prior to screening, whichever is longer
研究组 & 干预措施
1
Inhaled PT001 18 μg
干预措施: PT001 (Drug)
2
Inhaled PT005 2.4 μg
干预措施: PT005 (Drug)
3
Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)
干预措施: PT003 (Drug)
4
PT001 18 μg + PT005 2.4 μg
干预措施: PT001 + PT005 (Drug)
结局指标
主要结局
Symptoms of Dry Mouth
时间窗: 12 hours
Number of participants reporting dry mouth at 12 hours post-dose
Symptoms of Tremor
时间窗: 12 hours
Number of participants reporting tremor at 12 hours post-dose
Blood Chemistry Change From Baseline
时间窗: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Series of 11 blood chemistries assessed throughout the study
Hematology Change From Baseline
时间窗: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study Hemoglobin
Heart Rate Change From Baseline
时间窗: 12 hours
Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)
Vital Sign Change Baseline; Blood Pressure
时间窗: 12 hours
Vital sign change baseline; blood pressure
Vital Sign Change From Baseline, SpO2
时间窗: 12 hours
Vital Sign Change from baseline 12-hours post-dose SpO2 (%)
ECG Change From Baseline
时间窗: 12 hours
Change from baseline for ECG parameters 12-hours post-dose
Spirometry Change From Baseline
时间窗: 12 hours
Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)
Serum Potassium Change From Baseline
时间窗: 12 hours
次要结局
- Plasma Glycopyrrolate PK Parameters(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Glycopyrrolate PK Parameters (Tmax)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Glycopyrrolate PK Parameters (t1/2)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Glycopyrrolate PK Parameters (ke)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Formoterol PK Parameters(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Formoterol PK Parameters (Tmax)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Formoterol PK Parameters (t1/2)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Formoterol PK Parameters (Cmax)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)
- Plasma Formoterol PK Parameters (ke)(Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose)