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

NCT ID: NCT04157933

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2020-03-06

Brief Summary

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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

Detailed Description

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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

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A-1a

Part A, Arm 1 (active), Dose 1 (009-A1)

Group Type EXPERIMENTAL

009-A1

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 1 (low dose) each day for first 5 days, then 3 doses Dose 1 (low dose) q 2 hr on Day 6

A-2a

Part A, Arm 2 (active), Dose 2 (009-A2)

Group Type EXPERIMENTAL

009-A2

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 2 (middle dose) each day for first 5 days, then 3 doses Dose 2 (middle dose) q 2 hr on Day 6

A-3a

Part A, Arm 3 (active), Dose 3 (009-A3)

Group Type EXPERIMENTAL

009-A3

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 3 (high dose) each day for first 5 days, then 3 doses Dose 3 (high dose) q 2 hr on Day 6

A-0p

Part A, placebo comparator in all 3 arms, placebo dose (009-A0)

Group Type PLACEBO_COMPARATOR

009-A0

Intervention Type DRUG

Inhaled placebo via Staccato aerosol, Dose 0 (placebo) each day for first 5 days, then 3 doses Dose 0 (placebo) q 2 hr on Day 6

B-1 (009-B3 -> 009-B0)

Crossover (active to placebo)

Group Type EXPERIMENTAL

009-B1 (active --> placebo) crossover

Intervention Type DRUG

Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 2

B-1 (009-B0 -> 009-B3)

Crossover (placebo to active)

Group Type EXPERIMENTAL

009-B2 (placebo --> active) crossover

Intervention Type DRUG

Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 2

Interventions

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009-A1

Inhaled apomorphine via Staccato aerosol, Dose 1 (low dose) each day for first 5 days, then 3 doses Dose 1 (low dose) q 2 hr on Day 6

Intervention Type DRUG

009-A2

Inhaled apomorphine via Staccato aerosol, Dose 2 (middle dose) each day for first 5 days, then 3 doses Dose 2 (middle dose) q 2 hr on Day 6

Intervention Type DRUG

009-A3

Inhaled apomorphine via Staccato aerosol, Dose 3 (high dose) each day for first 5 days, then 3 doses Dose 3 (high dose) q 2 hr on Day 6

Intervention Type DRUG

009-A0

Inhaled placebo via Staccato aerosol, Dose 0 (placebo) each day for first 5 days, then 3 doses Dose 0 (placebo) q 2 hr on Day 6

Intervention Type DRUG

009-B1 (active --> placebo) crossover

Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 2

Intervention Type DRUG

009-B2 (placebo --> active) crossover

Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males and females between 30 and 85 years of age, inclusive at the time of signing the informed consent document with a clinical diagnosis of Parkinson's Disease
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexza Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geert J Groeneveld, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Human Drug Research (The Netherlands)

Locations

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Centre for Human Drug Research

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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AMDC-009-102

Identifier Type: -

Identifier Source: org_study_id