NCT03822364

Staccato Apomorphine Single and Multi Dose PK

A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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 each part are as follows. Part A: To compare the pharmacokinetics of a single low dose of AZ-009 with that of a therapeutically-relevant dose a commercially available apomorphine injector in healthy volunteers. Part B: To examine the tolerability and safety of AZ-009 of single ascending doses of active drug in healthy volunteers while; and to characterize the pharmacokinetics of single ascending doses of AZ-009 in healthy volunteers Part C: To examine the tolerability, safety, and pharmacokinetics of AZ-009 in subjects with established Parkinson's disease and to identify optimal doses to bring into multiple ascending dose safety and efficacy studies; and to assess the usability of AZ-009 in subjects with Parkinson's Disease

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	009-1	Inhaled apomorphine via Staccato aerosol, Dose 1
DRUG	active comparator	commercially available apomorphine injector
DRUG	009-0	Inhaled placebo via Staccato device
DRUG	009-2	Inhaled apomorphine via Staccato aerosol, Dose 2
DRUG	009-3	Inhaled apomorphine via Staccato aerosol, Dose 3
DRUG	009-4	Inhaled apomorphine via Staccato aerosol, Dose 4
DRUG	009-5	Inhaled apomorphine via Staccato aerosol, Dose 5

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-03-26
• Completion: 2019-03-26
• First posted: 2019-01-30
• Last updated: 2019-08-30

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study