Staccato Apomorphine Single and Multi Dose PK
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring apomorphine, aerosol
Eligibility Criteria
Inclusion Criteria:
- Healthy adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
- Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2.
- Willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Exclusion Criteria:
- 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.
- History of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss surgical procedure; or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial.
- Use of non-prescription medications within 5 days prior to the first dose of study drug.
- Use of medication that is inhibitor or inducer of CYP450-3A4/5 within 3 days of dosing.
- Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 3 days prior to administration of study drug.
Sites / Locations
- Center for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
A-1 (009-1 -> active comparator)
A-2 (active comparator -> 009-1)
B-1a (009-2)
B-1p (009-0)
B-2a (009-3)
B-2p (009-0)
B-3a (009-4)
B-3p (009-0)
C-1a (009-3)
C-1p (009-0)
C-2a (009-4)
C-2p (009-0)
C-3a (009-5)
C-3p (009-0)
Part A, Arm 1 (Inhaled apomorphine, Dose 1 followed by commercially available active comparator)
Part A, Arm 2 (commercially available active comparator followed by Inhaled apomorphine, Dose 1)
Part B, Arm 1 (Inhaled apomorphine, Dose 2)
Part B, Arm 1 (Inhaled placebo)
Part B, Arm 2 (Inhaled apomorphine, Dose 3)
Part B, Arm 2 (Inhaled placebo)
Part B, Arm 3 (Inhaled apomorphine, Dose 4)
Part B, Arm 3 (Inhaled placebo)
Part C, Arm 1 (Inhaled apomorphine, Dose 3)
Part C, Arm 1 (Inhaled placebo)
Part C, Arm 2 (Inhaled apomorphine, Dose 4)
Part C, Arm 2 (Inhaled placebo)
Part C, Arm 3 (Inhaled apomorphine, Dose 5)
Part C, Arm 3 (Inhaled placebo)