A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of BPN-14967 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to maximum observed plasma concentration (Tmax)
研究概览
简要总结
This is single center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of BPN-14967 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female (not of childbearing potential), 18 to 65 years of age, inclusive, at screening.
- •The subject voluntarily consents to participate in this study and
- •provides written informed consent before the start of any study-specific procedures.
- •The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
- •Female subjects must be of non-childbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or
- •bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening).
- •Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or agree to use a condom with spermicide when sexually active with a female partner. Male subjects must also agree to refrain from sperm donation for 90 days after study drug administration.
- •The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, at screening and weighs 50 to 100 kg (110-220 pounds), inclusive, at screening and Check-in.
- •The subject is considered to be in stable health by the investigator
- •Exclusion Criteria
- •Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
- •Any recent viral or bacterial infection.
- •Participated in any clinical study in last 6 weeks.
- •History of significant drug allergy
- •History of significant vision, ocular or retinal disorder.
- •Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations
- •Other protocol-defined inclusion/exclusion criteria could apply.
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 (fasted condition)
10 mg BPN-14967 or placebo
干预措施: BPN-14967 (Drug)
Cohort 1 (fasted condition)
10 mg BPN-14967 or placebo
干预措施: Placebo (Drug)
Cohort 2 (fasted condition)
25 mg BPN-14967 or placebo
干预措施: BPN-14967 (Drug)
Cohort 2 (fasted condition)
25 mg BPN-14967 or placebo
干预措施: Placebo (Drug)
Cohort 3 (fasted condition)
50 mg BPN-14967 or placebo
干预措施: BPN-14967 (Drug)
Cohort 3 (fasted condition)
50 mg BPN-14967 or placebo
干预措施: Placebo (Drug)
Cohort 4 (fed condition)
10 mg BPN-14967 or placebo
干预措施: BPN-14967 (Drug)
Cohort 4 (fed condition)
10 mg BPN-14967 or placebo
干预措施: Placebo (Drug)
Cohort 5 (high-fat fed condition)
10 mg BPN-14967 or placebo
干预措施: BPN-14967 (Drug)
Cohort 5 (high-fat fed condition)
10 mg BPN-14967 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to maximum observed plasma concentration (Tmax)
时间窗: Up to Day 8
Number of participants with Ocular Examination Abnormalities
时间窗: Up to Day 10
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)]
时间窗: Up to Day 8
Number of participants with Physical Examination Abnormalities
时间窗: Up to Day 10
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
时间窗: Up to Day 10
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
时间窗: Up to Day 8
Terminal elimination rate constant
时间窗: Up to Day 8
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
时间窗: Up to Day 10
Number of participants with Vital Sign Abnormalities
时间窗: Up to Day 10
Number of participants with changes in visual acuity
时间窗: Baseline and Day 10
Terminal phase half-life (t1/2)
时间窗: Up to Day 8
Number of participants with changes in color vision
时间窗: Baseline and Day 10
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 8
Apparent total body clearance (CL/F)
时间窗: Up to Day 8
Apparent volume of distribution (Vz/F)
时间窗: Up to Day 8
Number of participants with Clinical Laboratory Results Abnormalities
时间窗: Up to Day 10
次要结局
未报告次要终点