NCT05610189已完成1 期
A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Tavapadon
研究概览
简要总结
The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index of 17.5 to 38.0 kilograms per square meter (kg/m^2), inclusive, and total body weight >50 kg (110 pounds [lb]) at Screening.
- •Participants with a diagnosis of Parkinson's disease (PD) that is consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank diagnostic criteria.
- •Must be modified Hoehn & Yahr Stage I-III inclusive.
- •Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (e.g., L-Dopa/carbidopa, L Dopa/carbidopa/entacapone or L-Dopa/benserazide) administered at least 3 times per day for at least 2 weeks prior to the Day 1 Visit.
排除标准
- •Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism).
- •Participants with a history of psychosis or hallucinations within the previous 12 months.
- •Participants with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity are excluded. Participants with a history of febrile seizures only are allowed with medical monitor approval.
- •History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to signing the informed consent form (ICF).
- •Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
- •Participants who have attempted suicide in the past.
- •Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
- •Have been diagnosed with symptomatic coronavirus disease (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for COVID-19 within 30 days prior to signing the ICF.
- •Participants taking strong or moderate cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inducers or inhibitors or who would be likely to require concomitant therapy with CYP3A4 inducers or inhibitors during the trial.
- •NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
Experimental
Participants will receive tavapadon 1x15 mg tablet, orally, once daily (QD) from Day 15 to 21.
Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 22 to 28.
干预措施: Tavapadon (Drug)
Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg
Experimental
Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 15 to 21.
Participants will receive tavapadon 1x15 mg tablet, orally, QD from Day 22 to 28.
干预措施: Tavapadon (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
时间窗: Pre-dose and at multiple timepoints post-dose up to Day 28
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
时间窗: Pre-dose and at multiple timepoints post-dose up to Day 28
次要结局
- Peak-to-Trough Ratio (PTR) of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Time of Maximum Observed Concentration (Tmax) of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Apparent Clearance of Tavapadon From Plasma (CL/F)(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Number of Participants With Adverse Events (AEs) and AEs by Severity(Up to Day 36)
- Trough Concentration (Ctrough) of Tavapadon(Pre-dose and at multiple timepoints post-dose up to Day 28)
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values(Up to Day 29)
- Number of Participants With Clinically Significant Changes in Vital Sign Values(Up to Day 29)
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments(Up to Day 29)
- Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results(Up to Day 29)
- Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to Day 29)
研究者
研究点 (6)
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