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CompletedNCT03822364Updated Aug 30, 2019

Staccato Apomorphine Single and Multi Dose PK

A Phase 1 interventional study of 009-1 and active comparator in Parkinson Disease, sponsored by Alexza Pharmaceuticals, Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Alexza Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

Read the detailed description

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

02

Conditions studied

  • Parkinson Disease

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Keywords

  • apomorphine
  • aerosol
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 56 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Alexza Pharmaceuticals, Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 13 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

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

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

    Drug: 009-1 · Drug: active comparator

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

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

    Drug: 009-1 · Drug: active comparator

  • Experimental
    B-1a (009-2)

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

    Drug: 009-2

  • Placebo comparator
    B-1p (009-0)

    Part B, Arm 1 (Inhaled placebo)

    Drug: 009-0

  • Active comparator
    B-2a (009-3)

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

    Drug: 009-3

  • Placebo comparator
    B-2p (009-0)

    Part B, Arm 2 (Inhaled placebo)

    Drug: 009-0

  • Experimental
    B-3a (009-4)

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

    Drug: 009-4

  • Placebo comparator
    B-3p (009-0)

    Part B, Arm 3 (Inhaled placebo)

    Drug: 009-0

  • Experimental
    C-1a (009-3)

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

    Drug: 009-3

  • Placebo comparator
    C-1p (009-0)

    Part C, Arm 1 (Inhaled placebo)

    Drug: 009-0

  • Experimental
    C-2a (009-4)

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

    Drug: 009-4

  • Placebo comparator
    C-2p (009-0)

    Part C, Arm 2 (Inhaled placebo)

    Drug: 009-0

  • Experimental
    C-3a (009-5)

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

    Drug: 009-5

  • Placebo comparator
    C-3p (009-0)

    Part C, Arm 3 (Inhaled placebo)

    Drug: 009-0

Interventions

  • Drug009-1

    Inhaled apomorphine via Staccato aerosol, Dose 1

  • Drugactive comparator

    commercially available apomorphine injector

  • Drug009-0

    Inhaled placebo via Staccato device

  • Drug009-2

    Inhaled apomorphine via Staccato aerosol, Dose 2

  • Drug009-3

    Inhaled apomorphine via Staccato aerosol, Dose 3

  • Drug009-4

    Inhaled apomorphine via Staccato aerosol, Dose 4

  • Drug009-5

    Inhaled apomorphine via Staccato aerosol, Dose 5

06

What researchers measure

Primary outcomes

  1. A-Relative bioavailability of inhaled Staccato apomorphine dose compared to the subcutaneous administration

    Relative bioavailability of inhaled Staccato apomorphine compared to active comparator injection based on the Geometric Least Squares Mean Ratio of AUCinf for all subjects completing the crossover part of the trial

    Time frame: 24 hours

  2. B-Dose Proportionality by Power Analysis of AUCinf

    Dose proportionality of inhaled Staccato apomorphine AUCinf across all doses administered in the single ascending dose portions of the study (Parts B and C) using a power model \[regression of log(AUCinf) versus log(dose)\]

    Time frame: 24 hours

07

Study locations

1 site
  • Center for Human Drug Research
    Leiden, 2333 CL, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03822364
Lead sponsor
Alexza Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jan 30, 2019
Start date
Nov 26, 2018
Primary completion
Mar 26, 2019
Completion
Mar 26, 2019
Last update
Aug 30, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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