A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
- •Females, Non-Childbearing Potential due to meeting the following criteria:
- •Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
- •Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
- •Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity rating scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
- •Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.
研究组 & 干预措施
Tavapadon: Part 1-Sequence 1
Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2
干预措施: Tavapadon (Drug)
Tavapadon: Part 1-Sequence 2
Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2
干预措施: Tavapadon (Drug)
Tavapadon: Part 2-Sequence 1
Participants will receive Clinical Tavapadon Dose C in Period 1, Clinical Tavapadon Dose D in Period 2 followed by Commercial Tavapadon Dose E in Period 3
干预措施: Tavapadon (Drug)
Tavapadon: Part 2-Sequence 2
Participants will receive Clinical Tavapadon Dose C in Period 1, Commercial Tavapadon Dose E in Period 2 followed by Clinical Tavapadon Dose D in Period 3
干预措施: Tavapadon (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 53 days
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
时间窗: Up to approximately 22 days
(Cmax) of Tavapadon
Time to Cmax (Tmax) of Tavapadon
时间窗: Up to approximately 22 days
Tmax of Tavapadon
Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon
时间窗: Up to approximately 22 days
Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon
Terminal Phase Elimination Half-life (t1/2) of Tavapadon
时间窗: Up to approximately 22 days
Terminal Phase Elimination Half-life (t1/2) of Tavapadon
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
时间窗: Up to approximately 22 days
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
时间窗: Up to approximately 22 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Trough Concentration (Ctrough) of Tavapadon
时间窗: Up to approximately 22 days
Trough Concentration (Ctrough) of Tavapadon
次要结局
未报告次要终点