Volunteers on Chronic, Stable Antipsychotic RegimensPhase 1NCT00555412
Staccato Loxapine Multidose PK
A Phase 1 study testing A - 10 mg loxapine q 4 h x 3 (30 mg total), B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) and C - 5 mg loxapine q 4 h x 3 (15 mg total) in people with Volunteers on Chronic, Stable Antipsychotic Regimens, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Volunteers on Chronic, Stable Antipsychotic Regimens
- What is being tested?
- A - 10 mg loxapine q 4 h x 3 (30 mg total), B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) and C - 5 mg loxapine q 4 h x 3 (15 mg total)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between the ages of 18 to 65 years, inclusive.
- Subjects who are on stable, oral, chronic (>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.
Who cannot join
- Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.
- Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.
- Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
- Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.
- Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.
Read the detailed description
The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.
- Being tested
- A - 10 mg loxapine q 4 h x 3 (30 mg total), B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total), C - 5 mg loxapine q 4 h x 3 (15 mg total), D - inhaled placebo q 4 h x 3
- Keywords
- pharmacokinetic, multidose, Staccato Loxapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A - 10 mg loxapine q 4 h x 3 (30 mg total)Drug
Also called Staccato Loxapine 10 mg
loxapine aerosol inhalation high dose regimen (30 mg total)
B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)Drug
Also called Staccato Loxapine 5 and 10 mg
loxapine aerosol inhalation middle dose regimen (20 mg total)
C - 5 mg loxapine q 4 h x 3 (15 mg total)Drug
Also called Staccato Loxapine 5 mg
loxapine aerosol inhalation low dose regimen (15 mg total)
D - inhaled placebo q 4 h x 3Drug
Also called Staccato Placebo
placebo aerosol inhalation (0 mg total)
| Study group | Role | What they receive |
|---|---|---|
| A - 10 mg loxapine q 4 h x 3 (30 mg total) | Experimental | Not described Receives: Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total) |
| B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) | Experimental | Not described Receives: Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) |
| C - 5 mg loxapine q 4 h x 3 (15 mg total) | Experimental | Not described Receives: Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total) |
| D - inhaled placebo q 4 h x 3 | Placebo comparator | Not described Receives: Drug: D - inhaled placebo q 4 h x 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.
Measured: 48 hours
Secondary outcomes (2)
Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group
Measured: 24 hours
Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.
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 posted8 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Volunteers on Chronic, Stable Antipsychotic RegimensStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Collaborators
- Atlanta Center for Medical Research
- Responsible party
- Sponsor
- Investigators
- Robert Riesenberg, MD, Principal investigator, Atlanta Center for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555412
- Sponsor's protocol ID
- AMDC-004-102
- Status last verified
- Jun 2013
- First submitted
- 6 Nov 2007
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Publications
Spyker DA, Riesenberg RA, Cassella JV. Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens. J Clin Pharmacol. 2015 Sep;55(9):985-94. doi: 10.1002/jcph.502. Epub 2015 May 6.
PubMed 25808074
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
- ClinicalTrials.gov ID
- NCT00555412
- Acronym / sponsor ID
- AMDC-004-102
- Keywords
- pharmacokinetic, multidose, Staccato Loxapine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Collaborators
- Atlanta Center for Medical Research
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Nov 2007 (estimated)
- 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.
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.
Detailed description
The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - 10 mg loxapine q 4 h x 3 (30 mg total) | Experimental | Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total) |
| B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) | Experimental | Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) |
| C - 5 mg loxapine q 4 h x 3 (15 mg total) | Experimental | Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total) |
| D - inhaled placebo q 4 h x 3 | Placebo comparator | Drug: D - inhaled placebo q 4 h x 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects between the ages of 18 to 65 years, inclusive.
- Subjects who are on stable, oral, chronic (>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.
Key exclusion criteria (5 listed)
- Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.
- Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.
- Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
- Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.
- Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
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 |
|---|---|---|
| A - 10 mg loxapine q 4 h x 3 (30 mg total)Also: Staccato Loxapine 10 mgloxapine aerosol inhalation high dose regimen (30 mg total) | Drug | A - 10 mg loxapine q 4 h x 3 (30 mg total) |
| B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)Also: Staccato Loxapine 5 and 10 mgloxapine aerosol inhalation middle dose regimen (20 mg total) | Drug | B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) |
| C - 5 mg loxapine q 4 h x 3 (15 mg total)Also: Staccato Loxapine 5 mgloxapine aerosol inhalation low dose regimen (15 mg total) | Drug | C - 5 mg loxapine q 4 h x 3 (15 mg total) |
| D - inhaled placebo q 4 h x 3Also: Staccato Placeboplacebo aerosol inhalation (0 mg total) | Drug | D - inhaled placebo q 4 h x 3 |
Primary outcome
PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.
Time frame: 48 hours
2 secondary outcomes
Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group
Time frame: 24 hours
Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.
Time frame: 24 hours
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 15 Mar 2017.
- Background: PubMed 25808074Spyker DA, Riesenberg RA, Cassella JV. Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens. J Clin Pharmacol. 2015 Sep;55(9):985-94. doi: 10.1002/jcph.502. Epub 2015 May 6.
- Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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.
Robert Riesenberg, MD principal investigator
Atlanta Center for Medical Research
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 A - 10 mg loxapine q 4 h x 3 (30 mg total), B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) and C - 5 mg loxapine q 4 h x 3 (15 mg total) in people with Volunteers on Chronic, Stable Antipsychotic Regimens, 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 2 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 15 Mar 2017. 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. 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?
PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555412, which also lists 1 linked publication.
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 15 Mar 2017.