HealthyPhase 1NCT04327765
Staccato® Granisetron Multiple Dose PK
A Phase 1 study testing 0.5mg AZ-010, 1mg AZ-010 and 3mg AZ-010 in people with Healthy, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0.5mg AZ-010, 1mg AZ-010 and 3mg AZ-010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 15 Aug 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
- Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
- Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.
Who cannot join
- Any significant medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers
Read the detailed description
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
- Conditions
- Healthy
- Being tested
- 0.5mg AZ-010, 1mg AZ-010, 3mg AZ-010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5mg AZ-010Combination product
Also called Staccato Placebo
Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
1mg AZ-010Combination product
Also called Staccato Placebo
Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
3mg AZ-010Combination product
Also called Staccato Placebo
Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single orally-inhaled dose Receives: Combination Product: 0.5mg AZ-010 |
| Cohort 2 | Experimental | Single orally-inhaled dose Receives: Combination Product: 1mg AZ-010 |
| Cohort 3 | Experimental | Single orally-inhaled dose Receives: Combination Product: 3mg AZ-010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Number of Subjects with Adverse Events as a measure of Safety and Tolerability
Measured: 8 days
Secondary outcomes (3)
Measurement of Granisetron Exposure in Plasma
AUC
Measured: 8 days
Measurement of Granisetron Maximum exposure in Plasma
Cmax
Measured: 8 days
Measurement of Granisetron Time to Maximum Exposure in Plasma
Tmax
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start10 Mar 2020
- Primary completion4 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Terry O'Reilly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327765
- Sponsor's protocol ID
- AMDC-010-102
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04327765
- Acronym / sponsor ID
- AMDC-010-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Collaborators
- Celerion
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 31 Mar 2020 (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.
To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers
Detailed description
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Combination Product: 0.5mg AZ-010Single orally-inhaled dose |
| Cohort 2 | Experimental | Combination Product: 1mg AZ-010Single orally-inhaled dose |
| Cohort 3 | Experimental | Combination Product: 3mg AZ-010Single orally-inhaled dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
- Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
- Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.
Key exclusion criteria (1 listed)
- Any significant medical condition
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 |
|---|---|---|
| 0.5mg AZ-010Also: Staccato PlaceboSubject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo | Combination product | Cohort 1 |
| 1mg AZ-010Also: Staccato PlaceboSubject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo | Combination product | Cohort 2 |
| 3mg AZ-010Also: Staccato PlaceboSubject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo | Combination product | Cohort 3 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 8 days
Number of Subjects with Adverse Events as a measure of Safety and Tolerability
3 secondary outcomes
Measurement of Granisetron Exposure in Plasma
Time frame: 8 days
Measurement of Granisetron Maximum exposure in Plasma
Time frame: 8 days
Measurement of Granisetron Time to Maximum Exposure in Plasma
Time frame: 8 days
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 Oct 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.
Terry O'Reilly, MD principal investigator
Celerion
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 0.5mg AZ-010, 1mg AZ-010 and 3mg AZ-010 in people with Healthy, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
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 3 inclusion and 1 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 Oct 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 United States. 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. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: 8 days). 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 Oct 2020.