Parkinson's disease
Conditions
Interventions
AZ-009 / placebo
Sponsors
Alexza Pharmaceuticals Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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 screening. - 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 of dosing - Subjects with a contra-indication for domperidone as per current domperidone SmPC. - Use of apomorphine. - Part B ONLY: Dementia indicated by MMSE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: - safety and tolerability of AZ-009 after several days of dosing - pharmacokinetics (values of AZ-009 in the blood over time) Part B: - safety and tolerability of AZ-009 - pharmacokinetics (values of AZ-009 in the blood over time) - effect of AZ-009 when given during an OFF period - user-friendliness of the AZ-009 inhalation device when used during an OFF (by asking the patient) | — |
Countries
Netherlands
Outcome results
None listed