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Staccato Apomorphine Single and Multi Dose PK

NCT ID: NCT03822364

Last Updated: 2019-08-30

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2019-03-26

Brief Summary

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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

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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

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Parkinson Disease

Keywords

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apomorphine aerosol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 3 part study including: A) Single Dose Crossover in Healthy Volunteers, B) Single Ascending Dose with placebo control in Healthy Volunteers, and C) Single Ascending Dose with placebo control in Subjects with Established Parkinson's Disease
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A-1 (009-1 -> active comparator)

Part A, Arm 1 (Inhaled apomorphine, Dose 1 followed by commercially available active comparator)

Group Type EXPERIMENTAL

009-1

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 1

active comparator

Intervention Type DRUG

commercially available apomorphine injector

A-2 (active comparator -> 009-1)

Part A, Arm 2 (commercially available active comparator followed by Inhaled apomorphine, Dose 1)

Group Type EXPERIMENTAL

009-1

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 1

active comparator

Intervention Type DRUG

commercially available apomorphine injector

B-1a (009-2)

Part B, Arm 1 (Inhaled apomorphine, Dose 2)

Group Type EXPERIMENTAL

009-2

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 2

B-1p (009-0)

Part B, Arm 1 (Inhaled placebo)

Group Type PLACEBO_COMPARATOR

009-0

Intervention Type DRUG

Inhaled placebo via Staccato device

B-2a (009-3)

Part B, Arm 2 (Inhaled apomorphine, Dose 3)

Group Type ACTIVE_COMPARATOR

009-3

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 3

B-2p (009-0)

Part B, Arm 2 (Inhaled placebo)

Group Type PLACEBO_COMPARATOR

009-0

Intervention Type DRUG

Inhaled placebo via Staccato device

B-3a (009-4)

Part B, Arm 3 (Inhaled apomorphine, Dose 4)

Group Type EXPERIMENTAL

009-4

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 4

B-3p (009-0)

Part B, Arm 3 (Inhaled placebo)

Group Type PLACEBO_COMPARATOR

009-0

Intervention Type DRUG

Inhaled placebo via Staccato device

C-1a (009-3)

Part C, Arm 1 (Inhaled apomorphine, Dose 3)

Group Type EXPERIMENTAL

009-3

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 3

C-1p (009-0)

Part C, Arm 1 (Inhaled placebo)

Group Type PLACEBO_COMPARATOR

009-0

Intervention Type DRUG

Inhaled placebo via Staccato device

C-2a (009-4)

Part C, Arm 2 (Inhaled apomorphine, Dose 4)

Group Type EXPERIMENTAL

009-4

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 4

C-2p (009-0)

Part C, Arm 2 (Inhaled placebo)

Group Type PLACEBO_COMPARATOR

009-0

Intervention Type DRUG

Inhaled placebo via Staccato device

C-3a (009-5)

Part C, Arm 3 (Inhaled apomorphine, Dose 5)

Group Type EXPERIMENTAL

009-5

Intervention Type DRUG

Inhaled apomorphine via Staccato aerosol, Dose 5

C-3p (009-0)

Part C, Arm 3 (Inhaled placebo)

Group Type PLACEBO_COMPARATOR

009-0

Intervention Type DRUG

Inhaled placebo via Staccato device

Interventions

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009-1

Inhaled apomorphine via Staccato aerosol, Dose 1

Intervention Type DRUG

active comparator

commercially available apomorphine injector

Intervention Type DRUG

009-0

Inhaled placebo via Staccato device

Intervention Type DRUG

009-2

Inhaled apomorphine via Staccato aerosol, Dose 2

Intervention Type DRUG

009-3

Inhaled apomorphine via Staccato aerosol, Dose 3

Intervention Type DRUG

009-4

Inhaled apomorphine via Staccato aerosol, Dose 4

Intervention Type DRUG

009-5

Inhaled apomorphine via Staccato aerosol, Dose 5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
* 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 surgical procedure; or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial.
* Use of non-prescription medications within 5 days prior to the first dose of study drug.
* Use of medication that is inhibitor or inducer of CYP450-3A4/5 within 3 days of dosing.
* Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 3 days prior to administration of study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Center for Human Drug Research

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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AMDC-009-101

Identifier Type: -

Identifier Source: org_study_id