Parkinson's DiseasePhase 1NCT04157933
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
A Phase 1 study testing 009-A1, 009-A2 and 009-A3 in people with Parkinson's Disease, run by Alexza Pharmaceuticals, Inc. at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- 009-A1, 009-A2 and 009-A3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Oct 2019to 6 Mar 2020
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Parkinson's Disease
- Being tested
- 009-A1, 009-A2, 009-A3, 009-A0, 009-B1 (active --> placebo) crossover
- 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-A1Drug
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
009-A2Drug
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
009-A3Drug
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
009-A0Drug
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
009-B1 (active --> placebo) crossoverDrug
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
009-B2 (placebo --> active) crossoverDrug
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
| Study group | Role | What they receive |
|---|---|---|
| A-1a | Experimental | Part A, Arm 1 (active), Dose 1 (009-A1) Receives: Drug: 009-A1 |
| A-2a | Experimental | Part A, Arm 2 (active), Dose 2 (009-A2) Receives: Drug: 009-A2 |
| A-3a | Experimental | Part A, Arm 3 (active), Dose 3 (009-A3) Receives: Drug: 009-A3 |
| A-0p | Placebo comparator | Part A, placebo comparator in all 3 arms, placebo dose (009-A0) Receives: Drug: 009-A0 |
| B-1 (009-B3 -> 009-B0) | Experimental | Crossover (active to placebo) Receives: Drug: 009-B1 (active --> placebo) crossover |
| B-1 (009-B0 -> 009-B3) | Experimental | Crossover (placebo to active) Receives: Drug: 009-B2 (placebo --> active) crossover |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 days
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.
Measured: 2 days
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.
Measured: 2 days
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start16 Oct 2019
- Primary completion28 Feb 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 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
- NCT04157933
- Sponsor's protocol ID
- AMDC-009-102
- Status last verified
- Aug 2019
- First submitted
- 1 Nov 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04157933
- Acronym / sponsor ID
- AMDC-009-102
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 8 Nov 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| A-1a | Experimental | Drug: 009-A1Part A, Arm 1 (active), Dose 1 (009-A1) |
| A-2a | Experimental | Drug: 009-A2Part A, Arm 2 (active), Dose 2 (009-A2) |
| A-3a | Experimental | Drug: 009-A3Part A, Arm 3 (active), Dose 3 (009-A3) |
| A-0p | Placebo comparator | Drug: 009-A0Part A, placebo comparator in all 3 arms, placebo dose (009-A0) |
| B-1 (009-B3 -> 009-B0) | Experimental | Drug: 009-B1 (active --> placebo) crossoverCrossover (active to placebo) |
| B-1 (009-B0 -> 009-B3) | Experimental | Drug: 009-B2 (placebo --> active) crossoverCrossover (placebo to active) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 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
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-A1Inhaled 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 | Drug | A-1a |
| 009-A2Inhaled 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 | Drug | A-2a |
| 009-A3Inhaled 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 | Drug | A-3a |
| 009-A0Inhaled 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 | Drug | A-0p |
| 009-B1 (active --> placebo) crossoverUp 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 | Drug | B-1 (009-B3 -> 009-B0) |
| 009-B2 (placebo --> active) crossoverUp 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 | Drug | B-1 (009-B0 -> 009-B3) |
Primary outcome
A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC
Time frame: 6 days
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
Time frame: 2 days
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
Time frame: 2 days
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
Time frame: 2 days
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.
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 4 Nov 2020.
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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-A1, 009-A2 and 009-A3 in people with Parkinson's 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 2 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 4 Nov 2020. 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 - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC (time frame: 6 days). The study lists 4 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 4 Nov 2020.