A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The pharmacokinetic profile of PT010
研究概览
简要总结
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
详细描述
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.
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
- •Informed Consent Form (ICF) prior to any study related procedures
- •Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive
- •Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, 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
PT010 Dose 1
PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
干预措施: PT010 Dose 1 (Drug)
PT010 Dose 2
PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
干预措施: PT010 Dose 2 (Drug)
Placebo MDI
Placebo MDI. Administered as 2 inhalations
干预措施: Placebo MDI (Drug)
结局指标
主要结局
The pharmacokinetic profile of PT010
时间窗: 12 hours
The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on: * maximum plasma concentration (Cmax) * area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12) * area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t) * area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1) * time to maximum plasma concentration (tmax) * apparent terminal elimination half-life (t½) * apparent total body clearance (CL/F) * apparent volume of distribution (Vd/F) * terminal elimination rate constant (λz) * accumulation ratio for Cmax (RAC \[Cmax\]) * accumulation ratio for AUC0 12 (RAC \[AUC0 12\]) Other PK parameters may be calculated, as appropriate.
次要结局
- Overall safety of PT010(12 hours)