A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of Prodrug PRX-P4-003 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Outcome
研究概览
简要总结
This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers.
详细描述
This study will evaluate the pharmacokinetics of a single oral microdose of PRX-P4-003 in healthy male volunteers in a fasted state (Study A) and a fed state (Study B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18 to 45 years
- •Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive)
- •Normal resting heart rate (50 to 100 bpm) and blood pressure (systolic 90-130 mmHg, diastolic 60-85 mmHg) at Screening and Day 0
- •Willingness to provide written informed consent and HIPAA authorization, and agreement to use a highly effective method of birth control during the study and for 1 month after study drug administration
- •Nonsmoker (no smoking within 6 months of Screening Visit 1); no medicinal or recreational marijuana use within 3 months prior to screening or during the study
- •Willingness to fast for at least 8 hours overnight and 4 hours post-dose (for Study A)
- •Ability to communicate well with the investigator and comply with clinic procedures
排除标准
- •History or presence of any clinically significant respiratory, gastrointestinal, renal, hepatic, hematological, neurological (including seizure history), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders
- •History of suicide attempts or current suicidal ideation
- •Clinically significant abnormal physical, neurological, or laboratory findings, or abnormal ECG (including average QTc interval ≥ 450 msec or a history of congenitally prolonged QT interval)
- •Need for prescription medications within 14 days (or 5 half-lives) prior to dosing
- •Acetaminophen use > 1000 mg (single dose) within 3 days prior to Day 1
- •Use of any investigational drug, medical device, or herbal medicine within 3 months prior to or during the study
- •Known hypersensitivity or intolerance to drugs with the same mechanism of action as PRX-P4-003 or (-)-fencamfamine
- •History of alcohol abuse (>4 drinks/day) or drug addiction within the past 2 years; positive urine drug or alcohol screen at Screening or Day -1
- •Unwillingness to refrain from alcohol or drugs 24 hours prior to Day -1 and during the inpatient stay
- •Seropositive for Hepatitis B, Hepatitis C, or known HIV infection
- •Donation or loss of > 500 mL of blood in the 8 weeks prior to dosing, or planned donation during trial participation
- •Inability or unwillingness to comply with protocol requirements/appointments, or inability to understand English (unless a certified translation of the informed consent is available)
研究组 & 干预措施
(-)-FCF - Fasted
Single 40 µg oral dose of (-)-fencamfamine hydrochloride [(-)-FCF HCl] administered under fasted conditions.
干预措施: (-)-FCF (Drug)
PRX-P4-003 - Fasted
Single 100 µg oral microdose of PRX-P4-003 administered under fasted conditions.
干预措施: PRX-P4-003 (Drug)
PRX-P4-003 - Fed
Single 100 µg oral microdose of PRX-P4-003 administered under fed conditions.
干预措施: PRX-P4-003 (Drug)
结局指标
主要结局
Outcome
时间窗: 24 hours
Plasma (-)-FCF exposure (AUC 0-t) after Oral dosing of PRX-P4-003 and (-)-FCF
Systemic Exposure (AUC0-t) of Active (-)-fencamfamine [(-)-FCF]
时间窗: Up to 24 hours post-dose (pre-dose [15-30 minutes prior], and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, and 24 hours post-dose)
Determination of the average exposure of active (-)-fencamfamine \[(-)-FCF\], as measured by the Area Under the plasma concentration-time Curve to the last measurable concentration (AUC0-t), following single oral microdose administration of PRX-P4-003 (100 µg) and the reference drug (-)-FCF HCl (40 µg).
次要结局
未报告次要终点