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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
009-A1
009-A2
009-A3
009-A0
009-B1 (active --> placebo) crossover
009-B2 (placebo --> active) crossover
Sponsored by
Alexza Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Human Drug Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

A-1a

A-2a

A-3a

A-0p

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

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

Arm Description

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

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

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

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

Crossover (active to placebo)

Crossover (placebo to active)

Outcomes

Primary Outcome Measures

A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC
Dose proportionality of inhaled Staccato apomorphine AUC across all 3 doses during Days 1-5 and multiple daily dosing (all 3 doses q 2 hr per day) on Day 6 using a power model [regression of log(AUC) versus log(dose)] in subjects with established Parkinson's disease
B1 - Effect on MDS-UPDRS in Parkinson's disease OFF periods
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in subjects with established Parkinson's disease experiencing regular OFF episodes.
B2 - Effect on Physician Disease State Assessment in Parkinson's disease OFF periods
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Physician Disease State Assessment in subjects with established Parkinson's disease experiencing regular OFF episodes.
B3 - Effect on Patient Assessment of ON/OFF in Parkinson's disease OFF periods
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on Patient Assessment of ON/OFF in subjects with established Parkinson's disease experiencing regular OFF episodes.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2019
Last Updated
November 3, 2020
Sponsor
Alexza Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04157933
Brief Title
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
Official Title
A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexza Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model 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 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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-1a
Arm Type
Experimental
Arm Description
Part A, Arm 1 (active), Dose 1 (009-A1)
Arm Title
A-2a
Arm Type
Experimental
Arm Description
Part A, Arm 2 (active), Dose 2 (009-A2)
Arm Title
A-3a
Arm Type
Experimental
Arm Description
Part A, Arm 3 (active), Dose 3 (009-A3)
Arm Title
A-0p
Arm Type
Placebo Comparator
Arm Description
Part A, placebo comparator in all 3 arms, placebo dose (009-A0)
Arm Title
B-1 (009-B3 -> 009-B0)
Arm Type
Experimental
Arm Description
Crossover (active to placebo)
Arm Title
B-1 (009-B0 -> 009-B3)
Arm Type
Experimental
Arm Description
Crossover (placebo to active)
Intervention Type
Drug
Intervention Name(s)
009-A1
Intervention Description
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
Intervention Name(s)
009-A2
Intervention Description
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
Intervention Name(s)
009-A3
Intervention Description
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
Intervention Name(s)
009-A0
Intervention Description
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
Intervention Name(s)
009-B1 (active --> placebo) crossover
Intervention Description
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
Intervention Name(s)
009-B2 (placebo --> active) crossover
Intervention Description
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
Primary Outcome Measure Information:
Title
A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC
Description
Dose proportionality of inhaled Staccato apomorphine AUC across all 3 doses during Days 1-5 and multiple daily dosing (all 3 doses q 2 hr per day) on Day 6 using a power model [regression of log(AUC) versus log(dose)] in subjects with established Parkinson's disease
Time Frame
6 days
Title
B1 - Effect on MDS-UPDRS in Parkinson's disease OFF periods
Description
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in subjects with established Parkinson's disease experiencing regular OFF episodes.
Time Frame
2 days
Title
B2 - Effect on Physician Disease State Assessment in Parkinson's disease OFF periods
Description
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Physician Disease State Assessment in subjects with established Parkinson's disease experiencing regular OFF episodes.
Time Frame
2 days
Title
B3 - Effect on Patient Assessment of ON/OFF in Parkinson's disease OFF periods
Description
Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on Patient Assessment of ON/OFF in subjects with established Parkinson's disease experiencing regular OFF episodes.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert J Groeneveld, MD, PhD
Organizational Affiliation
Center for Human Drug Research (The Netherlands)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Human Drug Research
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands

12. IPD Sharing Statement

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

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