Parkinson DiseasePhase 1NCT03822364
Staccato Apomorphine Single and Multi Dose PK
A Phase 1 study testing 009-1, active comparator and 009-0 in people with Parkinson Disease, run by Alexza Pharmaceuticals, Inc. at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 009-1, active comparator and 009-0
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Nov 2018to 26 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease
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
- Conditions
- Parkinson Disease
- Being tested
- 009-1, active comparator, 009-0, 009-2, 009-3
- Keywords
- apomorphine, aerosol
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
009-1Drug
Inhaled apomorphine via Staccato aerosol, Dose 1
active comparatorDrug
commercially available apomorphine injector
009-0Drug
Inhaled placebo via Staccato device
009-2Drug
Inhaled apomorphine via Staccato aerosol, Dose 2
009-3Drug
Inhaled apomorphine via Staccato aerosol, Dose 3
009-4Drug
Inhaled apomorphine via Staccato aerosol, Dose 4
009-5Drug
Inhaled apomorphine via Staccato aerosol, Dose 5
| Study group | Role | What they receive |
|---|---|---|
| A-1 (009-1 -> active comparator) | Experimental | Part A, Arm 1 (Inhaled apomorphine, Dose 1 followed by commercially available active comparator) Receives: Drug: 009-1; Drug: active comparator |
| A-2 (active comparator -> 009-1) | Experimental | Part A, Arm 2 (commercially available active comparator followed by Inhaled apomorphine, Dose 1) Receives: Drug: 009-1; Drug: active comparator |
| B-1a (009-2) | Experimental | Part B, Arm 1 (Inhaled apomorphine, Dose 2) Receives: Drug: 009-2 |
| B-1p (009-0) | Placebo comparator | Part B, Arm 1 (Inhaled placebo) Receives: Drug: 009-0 |
| B-2a (009-3) | Active comparator | Part B, Arm 2 (Inhaled apomorphine, Dose 3) Receives: Drug: 009-3 |
| B-2p (009-0) | Placebo comparator | Part B, Arm 2 (Inhaled placebo) Receives: Drug: 009-0 |
| B-3a (009-4) | Experimental | Part B, Arm 3 (Inhaled apomorphine, Dose 4) Receives: Drug: 009-4 |
| B-3p (009-0) | Placebo comparator | Part B, Arm 3 (Inhaled placebo) Receives: Drug: 009-0 |
| C-1a (009-3) | Experimental | Part C, Arm 1 (Inhaled apomorphine, Dose 3) Receives: Drug: 009-3 |
| C-1p (009-0) | Placebo comparator | Part C, Arm 1 (Inhaled placebo) Receives: Drug: 009-0 |
| C-2a (009-4) | Experimental | Part C, Arm 2 (Inhaled apomorphine, Dose 4) Receives: Drug: 009-4 |
| C-2p (009-0) | Placebo comparator | Part C, Arm 2 (Inhaled placebo) Receives: Drug: 009-0 |
| C-3a (009-5) | Experimental | Part C, Arm 3 (Inhaled apomorphine, Dose 5) Receives: Drug: 009-5 |
| C-3p (009-0) | Placebo comparator | Part C, Arm 3 (Inhaled placebo) Receives: Drug: 009-0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
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)]
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start26 Nov 2018
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Geert J Groeneveld, MD, PhD, Principal investigator, Center for Human Drug Research (The Netherlands)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822364
- Sponsor's protocol ID
- AMDC-009-101
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03822364
- Acronym / sponsor ID
- AMDC-009-101
- Conditions
- Parkinson Disease
- Keywords
- apomorphine, aerosol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| A-1 (009-1 -> active comparator) | Experimental | Drug: 009-1, Drug: active comparatorPart A, Arm 1 (Inhaled apomorphine, Dose 1 followed by commercially available active comparator) |
| A-2 (active comparator -> 009-1) | Experimental | Drug: 009-1, Drug: active comparatorPart A, Arm 2 (commercially available active comparator followed by Inhaled apomorphine, Dose 1) |
| B-1a (009-2) | Experimental | Drug: 009-2Part B, Arm 1 (Inhaled apomorphine, Dose 2) |
| B-1p (009-0) | Placebo comparator | Drug: 009-0Part B, Arm 1 (Inhaled placebo) |
| B-2a (009-3) | Active comparator | Drug: 009-3Part B, Arm 2 (Inhaled apomorphine, Dose 3) |
| B-2p (009-0) | Placebo comparator | Drug: 009-0Part B, Arm 2 (Inhaled placebo) |
| B-3a (009-4) | Experimental | Drug: 009-4Part B, Arm 3 (Inhaled apomorphine, Dose 4) |
| B-3p (009-0) | Placebo comparator | Drug: 009-0Part B, Arm 3 (Inhaled placebo) |
| C-1a (009-3) | Experimental | Drug: 009-3Part C, Arm 1 (Inhaled apomorphine, Dose 3) |
| C-1p (009-0) | Placebo comparator | Drug: 009-0Part C, Arm 1 (Inhaled placebo) |
| C-2a (009-4) | Experimental | Drug: 009-4Part C, Arm 2 (Inhaled apomorphine, Dose 4) |
| C-2p (009-0) | Placebo comparator | Drug: 009-0Part C, Arm 2 (Inhaled placebo) |
| C-3a (009-5) | Experimental | Drug: 009-5Part C, Arm 3 (Inhaled apomorphine, Dose 5) |
| C-3p (009-0) | Placebo comparator | Drug: 009-0Part C, Arm 3 (Inhaled placebo) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 009-1Inhaled apomorphine via Staccato aerosol, Dose 1 | Drug | A-1 (009-1 -> active comparator), A-2 (active comparator -> 009-1) |
| active comparatorcommercially available apomorphine injector | Drug | A-1 (009-1 -> active comparator), A-2 (active comparator -> 009-1) |
| 009-0Inhaled placebo via Staccato device | Drug | B-1p (009-0), B-2p (009-0), B-3p (009-0), C-1p (009-0), C-2p (009-0), C-3p (009-0) |
| 009-2Inhaled apomorphine via Staccato aerosol, Dose 2 | Drug | B-1a (009-2) |
| 009-3Inhaled apomorphine via Staccato aerosol, Dose 3 | Drug | B-2a (009-3), C-1a (009-3) |
| 009-4Inhaled apomorphine via Staccato aerosol, Dose 4 | Drug | B-3a (009-4), C-2a (009-4) |
| 009-5Inhaled apomorphine via Staccato aerosol, Dose 5 | Drug | C-3a (009-5) |
Primary outcome
A-Relative bioavailability of inhaled Staccato apomorphine dose compared to the subcutaneous administration
Time frame: 24 hours
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
B-Dose Proportionality by Power Analysis of AUCinf
Time frame: 24 hours
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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert J Groeneveld, MD, PhD principal investigator
Center for Human Drug Research (The Netherlands)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 009-1, active comparator and 009-0 in people with Parkinson Disease, run by Alexza Pharmaceuticals, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A-Relative bioavailability of inhaled Staccato apomorphine dose compared to the subcutaneous administration (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.