Status:
COMPLETED
Staccato Apomorphine Single and Multi Dose PK
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will be conducted in 3 parts. A) compare the pharmacokinetics (PK) of a single dose of AZ-009 with that of a therapeutically-relevant dose of a commercially available apomorphine injector i...
Detailed Description
This study will be conducted in 3 parts. Parts A and B will be conducted in healthy volunteers and Part C will be conducted in subjects with established Parkinson's disease. The primary objectives for...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03822364
Start Date
November 26 2018
End Date
March 26 2019
Last Update
August 30 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Human Drug Research
Leiden, Netherlands, 2333 CL