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Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease

2019-11-12 18:25:13 | BioPortfolio

Summary

This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design

Description

This study will be conducted in subjects with established Parkinson's disease in 2 parts.

Part A will examine the tolerability, safety, and pharmacokinetics of daily doses of AZ-009 for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts

Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in subjects with established Parkinson's disease experiencing regular OFF episodes

Study Design

Conditions

Parkinson's Disease

Intervention

009-A1, 009-A2, 009-A3, 009-A0, 009-B1 (active --> placebo) crossover, 009-B2 (placebo --> active) crossover

Location

Centre for Human Drug Research
Leiden
Netherlands
2333

Status

Enrolling by invitation

Source

Alexza Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-12T18:25:13-0500

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