Staccato Apomorphine Single and Multi Dose PK

• Status: Completed
• Trial end date: 2019-03-26
• Target enrollment: 0
• Participant gender: All

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 in healthy volunteers; B) ascending doses of active drug in healthy volunteers; and C) examine the tolerability, safety, and PK of AZ-009 in subjects with established Parkinson's disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexza Pharmaceuticals, Inc.
• Treatments: Apomorphine

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.