NL-OMON48411已完成不适用
A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects with Established Parkinson*s Disease - MAD study of AZ-009 in PD patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subjects between the ages of 30 and 85 (inclusive at the time of signing the
- •informed consent document) with a clinical diagnosis of PD.
- •- using medically acceptable contraception during the study and for 90 days
- •after the last dose of study drug.
- •- Healthy, as determined by the responsible physician, based on a medical
- •evaluation including history, physical examination, vital signs,
- •electrocardiograms (ECGs) and laboratory tests assessed at the screening visit
- •and prior to the first dose of study drug.
- •- Part A ONLY: Classified as Hoehn & Yahr stage I-IV in the ON state
- •- Part B ONLY: Subjects who experience motor fluctuations with recognizable OFF
- •periods as assessed by the Motor Fluctuation Questionnaire. Subjects should
- •respond at least one *yes* on the questionnaire.
- •- Part B ONLY: Classified as Hoehn & Yahr stage I-III in the ON state and have
- •clear, self-described motor fluctuations (confirmed by the Motor Fluctuation
- •Questionnaire) on optimized oral l-dopa or dopamine agonist therapy.
排除标准
- •- Use of 5HT3 antagonists
- •- Previous intolerance to apomorphine
- •- Symptomatic clinically relevant and medically uncontrolled orthostatic
- •hypotension.
- •- Subjects with a prolonged QT interval corrected for heart rate according to
- •Fridericia's formula (QTcF) of >450 ms for male and >470 ms for female at
- •screening or directly prior to first dosing, or a history of long QT syndrome.
- •Also subjects with a PR interval > 220 msec or QRS duration > 120 msec at
- •- Active hallucinations or history of hallucinations in the past 3 months. Any
- •significant medical condition, psychiatric illness or history of depression
- •that could, in the investigator*s opinion, compromise the subject*s safety or
- •interfere with the completion of this protocol.
- •- Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl
- •transferase (GGT), serum creatinine, or total bilirubin > 1.5 x upper limit of
- •normal (ULN) at screening or prior to the first dose of study drug. An
- •exception may be made for a suspected Gilbert*s syndrome.
- •- Use of medication that is inhibitor or inducer of CYP450-3A4/5 within 3 days
- •- Subjects with a contra-indication for domperidone as per current domperidone
- •- Use of apomorphine.
- •- Part B ONLY: Dementia indicated by MMSE <18 at Screening.
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