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Staccato Apomorphine Single and Multi Dose PK

NCT03822364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-08-30

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

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

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Geert J Groeneveld, MD, PhD · Center for Human Drug Research (The Netherlands)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2019-03-26
Completion
2019-03-26
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822364 on ClinicalTrials.gov