SchizophreniaPhase 1NCT00444028

Staccato Loxapine Single Dose PK

A Phase 1 study testing inhaled Loxapine 0.625 mg, inhaled Loxapine 1.25 mg and inhaled Loxapine 2.5 mg in people with Schizophrenia, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: inhaled Loxapine 0.625 mg, inhaled Loxapine 1.25 mg and inhaled Loxapine 2.5 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Sep 2005to Nov 2005
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female subjects between the ages of 18 to 55 years, inclusive.
Subjects with a body mass index (BMI) ≥21 and ≤30.
Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures.
Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) for approximately 2 days and comply with the study schedule and study requirements.
Subjects who are in good general health as determined by a complete medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, and urinalysis.

Who cannot join

Subjects who regularly consume large amounts of xanthine-containing substances (i.e., more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
Subjects who have taken prescription or nonprescription medication (with the exception of vitamins and acetaminophen if medically necessary) within 5 days of Visit 2 (Baseline).
Subjects who have had an acute illness within 5 days of Visit 2 (Baseline).
Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug, if >30 days) prior to Visit 2 (Baseline).
Subjects who have smoked tobacco within the last year.
Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4.

Show all 19Show fewer

Subjects with a history of HIV positivity.
Subjects with a history of allergy or intolerance to dibenzoxazepines (amoxapine and loxapine).
Subjects with a known history of contraindications to anticholinergics (bowel obstructions, urinary retention, acute glaucoma).
Subjects with a history of pheochromocytoma, seizure disorder, Parkinson's disease, or Restless Leg Syndrome (RLS).
Subjects who test positive for alcohol or have a positive urine drug screen at Visit 1 or Visit 2.
Subjects who have hypotension (systolic blood pressure ≤90 mmHg, diastolic blood pressure ≤50 mmHg), or hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).
Subjects who have a clinically significant ECG abnormality.
Subjects with a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), stroke, transient ischemic attack (TIA), or a neurological disorder.
Subjects who have a history of pulmonary disease that precludes administration of Staccato Loxapine (asthma, bronchitis, bronchospasm, emphysema).
Subjects who have an FEV1 less than 80% of predicted values on spirometry assessments at Visit 1.
Female subjects who are breastfeeding or have a positive pregnancy test at Visit 1 or Visit 2.
Female participants of child-bearing potential or within 1 year of menopause, and sexually active are excluded unless they use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception include abstinence, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and birth control pills. Unacceptable methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit Inc., d/b/a Covance GFI Research
Evansville, Indiana, 47714

Other trials in United States

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato™ Loxapine for Inhalation in Normal, Healthy Volunteers

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.

Read the detailed description

Safety and pharmacokinetic data obtained from 50 subjects (between the ages of 18 to 55 years) entered into this randomized, placebo-controlled study. To obtain 50 enrolled subjects, screening procedures and inclusion/exclusion criteria were evaluated for 126 subjects during a variable screening period of up to 21 days. Once enrolled, subjects were randomized to either Staccato Loxapine or Staccato placebo.

Plasma samples for pharmacokinetic analysis were collected beginning on Day 0, pre-dose and continuing for 24 hr post dose. Blood samples for the PK analysis of loxapine and its metabolites (8-OH loxapine, 7-OH loxapine and amoxapine) were obtained at time 0 (immediately before dosing), at 30 sec, 1, 2, 3, 5, 10, 30, 45 min, 1, 2, 4, 6, 12, 24 hr after dosing. Plasma concentrations of loxapine and metabolites were used to estimate the following PK parameters for loxapine and its metabolites: area under the plasma concentration time curve from time 0 extrapolated to infinity (AUCinf), AUC from time 0 to time tlast, the last quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), observed time of Cmax (tmax), terminal phase elimination rate constant (ke), apparent terminal elimination half life calculated from ke (T½ ), apparent total body clearance / fraction absorbed calculated from AUCinf and dose (CL/F) (for loxapine and the metabolites where permitted by measurable concentrations).

Safety was evaluated by the incidence of adverse events, clinical laboratory testing (blood chemistry, hematology, and urinalysis), physical examination, vital signs, pulse oximetry, postural vital signs, 12-lead electrocardiogram, pulmonary function tests, continuous 12-lead Holter monitoring, sedation assessments, akathisia assessments.

Conditions: Schizophrenia
Being tested: inhaled Loxapine 0.625 mg, inhaled Loxapine 1.25 mg, inhaled Loxapine 2.5 mg, inhaled Loxapine 5 mg, inhaled Loxapine 10 mg
Keywords: Schizophrenia, Staccato Loxapine
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

inhaled Loxapine 0.625 mgDrug
Also called ADASUVE
Single 0.625 mg (lowest) dose of inhaled loxapine
inhaled Loxapine 1.25 mgDrug
Also called ADASUVE
Single 1.25 mg (2nd) dose of inhaled loxapine
inhaled Loxapine 2.5 mgDrug
Also called ADASUVE
Single 2.5 mg (3rd) dose of inhaled loxapine
inhaled Loxapine 5 mgDrug
Also called ADASUVE
Single 5 mg (4th) dose of inhaled loxapine
inhaled Loxapine 10 mgDrug
Also called ADASUVE
Single 10 mg (5th) dose of inhaled loxapine
inhaled Placebo (0 mg)Drug
Also called PLACEBO
Single placebo dose of inhaled loxapine

Study groups in NCT00444028
Study group	Role	What they receive
Cohort A: Inhaled Loxapine 0.625 mg or Placebo	Experimental	Single 0.625 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine Receives: Drug: inhaled Loxapine 0.625 mg; Drug: inhaled Placebo (0 mg)
Cohort B: Inhaled Loxapine 1.25 mg or Placebo	Experimental	Single 1.25 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine Receives: Drug: inhaled Loxapine 1.25 mg; Drug: inhaled Placebo (0 mg)
Cohort C: Inhaled Loxapine 2.5 mg or Placebo	Experimental	Single 2.5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine Receives: Drug: inhaled Loxapine 2.5 mg; Drug: inhaled Placebo (0 mg)
Cohort D: Inhaled Loxapine 5 mg or Placebo	Experimental	Single 5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine Receives: Drug: inhaled Loxapine 5 mg; Drug: inhaled Placebo (0 mg)
Cohort E: Inhaled Loxapine 10 mg or Placebo	Experimental	Single 10 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine Receives: Drug: inhaled Loxapine 10 mg; Drug: inhaled Placebo (0 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Tmax
Tmax = time from inhalation to to maximum observed loxapine concentration
Measured: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Half-life
Half-life of the terminal elimination phase of loxapine concentrations
Measured: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
ke
elimination rate constant
Measured: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Clearance
clearance (CL/F) of lozxapine
Measured: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Cmax
maximum concentration of loxapine observed
Measured: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Dose Proportionality (AUCinf) by Power Analysis
Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being "perfect". Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is "as good as it gets".
Measured: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Nov 2005

First posted7 Mar 2007 (estimated)
Study startSep 2005
Primary completionNov 2005
Study completionNov 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00444028
Sponsor's protocol ID: AMDC-004-101
Status last verified: Mar 2007
First submitted: 5 Mar 2007
Last updated: 20 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
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, Munzar P, Cassella JV. Pharmacokinetics of loxapine following inhalation of a thermally generated aerosol in healthy volunteers. J Clin Pharmacol. 2010 Feb;50(2):169-79. doi: 10.1177/0091270009347866. Epub 2009 Nov 13.
PubMed 19915181

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato™ Loxapine for Inhalation in Normal, Healthy Volunteers
ClinicalTrials.gov ID: NCT00444028
Acronym / sponsor ID: AMDC-004-101
Conditions: Schizophrenia
Keywords: Schizophrenia, Staccato Loxapine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Alexza Pharmaceuticals, Inc.
Study start: Sep 2005
Primary completion: Nov 2005 (actual)
Study completion: Nov 2005 (actual)
First posted: 7 Mar 2007 (estimated)
Results: Posted 20 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Cohort A: Inhaled Loxapine 0.625 mg or Placebo	Experimental	Drug: inhaled Loxapine 0.625 mg, Drug: inhaled Placebo (0 mg)Single 0.625 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine
Cohort B: Inhaled Loxapine 1.25 mg or Placebo	Experimental	Drug: inhaled Loxapine 1.25 mg, Drug: inhaled Placebo (0 mg)Single 1.25 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine
Cohort C: Inhaled Loxapine 2.5 mg or Placebo	Experimental	Drug: inhaled Loxapine 2.5 mg, Drug: inhaled Placebo (0 mg)Single 2.5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine
Cohort D: Inhaled Loxapine 5 mg or Placebo	Experimental	Drug: inhaled Loxapine 5 mg, Drug: inhaled Placebo (0 mg)Single 5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine
Cohort E: Inhaled Loxapine 10 mg or Placebo	Experimental	Drug: inhaled Loxapine 10 mg, Drug: inhaled Placebo (0 mg)Single 10 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male and female subjects between the ages of 18 to 55 years, inclusive.
Subjects with a body mass index (BMI) ≥21 and ≤30.
Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures.
Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) for approximately 2 days and comply with the study schedule and study requirements.
Subjects who are in good general health as determined by a complete medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, and urinalysis.

Key exclusion criteria (19 listed)

Subjects who regularly consume large amounts of xanthine-containing substances (i.e., more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
Subjects who have taken prescription or nonprescription medication (with the exception of vitamins and acetaminophen if medically necessary) within 5 days of Visit 2 (Baseline).
Subjects who have had an acute illness within 5 days of Visit 2 (Baseline).
Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug, if >30 days) prior to Visit 2 (Baseline).
Subjects who have smoked tobacco within the last year.

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
inhaled Loxapine 0.625 mgAlso: ADASUVESingle 0.625 mg (lowest) dose of inhaled loxapine	Drug	Cohort A: Inhaled Loxapine 0.625 mg or Placebo
inhaled Loxapine 1.25 mgAlso: ADASUVESingle 1.25 mg (2nd) dose of inhaled loxapine	Drug	Cohort B: Inhaled Loxapine 1.25 mg or Placebo
inhaled Loxapine 2.5 mgAlso: ADASUVESingle 2.5 mg (3rd) dose of inhaled loxapine	Drug	Cohort C: Inhaled Loxapine 2.5 mg or Placebo
inhaled Loxapine 5 mgAlso: ADASUVESingle 5 mg (4th) dose of inhaled loxapine	Drug	Cohort D: Inhaled Loxapine 5 mg or Placebo
inhaled Loxapine 10 mgAlso: ADASUVESingle 10 mg (5th) dose of inhaled loxapine	Drug	Cohort E: Inhaled Loxapine 10 mg or Placebo
inhaled Placebo (0 mg)Also: PLACEBOSingle placebo dose of inhaled loxapine	Drug	Cohort A: Inhaled Loxapine 0.625 mg or Placebo, Cohort B: Inhaled Loxapine 1.25 mg or Placebo, Cohort C: Inhaled Loxapine 2.5 mg or Placebo, Cohort D: Inhaled Loxapine 5 mg or Placebo, Cohort E: Inhaled Loxapine 10 mg or Placebo

Primary outcome

Tmax
Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Tmax = time from inhalation to to maximum observed loxapine concentration
Half-life
Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Half-life of the terminal elimination phase of loxapine concentrations
ke
Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
elimination rate constant
Clearance
Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
clearance (CL/F) of lozxapine
Cmax
Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
maximum concentration of loxapine observed
Dose Proportionality (AUCinf) by Power Analysis
Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being "perfect". Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is "as good as it gets".

Results and safety

Results posted to the registry on 20 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	14	14
Staccato Loxapine 0.625 mg	7	7
Staccato Loxapine 1.25 mg	8	8
Staccato Loxapine 2.5 mg	6	6
Staccato Loxapine 5 mg	7	7
Staccato Loxapine 10 mg	8	8

Primary outcome: Tmax

Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours. Mean (Standard Deviation). Unit: minutes

Measure	Staccato Loxapine 0.625 mg n = 7	Staccato Loxapine 1.25 mg n = 8	Staccato Loxapine 2.5 mg n = 6	Staccato Loxapine 5 mg n = 7	Staccato Loxapine 10 mg n = 8
Value	12.6 (21.3)	2.15 (1.31)	2.87 (3.62)	2.13 (0.687)	5.25 (10)

Population analysed: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data

Primary outcome: Half-life

Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours. Mean (Standard Deviation). Unit: hours

Measure	Staccato Loxapine 0.625 mg n = 7	Staccato Loxapine 1.25 mg n = 8	Staccato Loxapine 2.5 mg n = 6	Staccato Loxapine 5 mg n = 7	Staccato Loxapine 10 mg n = 8
Value	5.2 (1.3)	6.56 (1.44)	6.92 (1.94)	6.2 (1.14)	6.14 (2.16)

Population analysed: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data

Primary outcome: ke

Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours. Mean (Standard Error). Unit: /hour

Measure	Staccato Loxapine 0.625 mg n = 7	Staccato Loxapine 1.25 mg n = 8	Staccato Loxapine 2.5 mg n = 6	Staccato Loxapine 5 mg n = 7	Staccato Loxapine 10 mg n = 8
Value	.143 (.047)	.111 (.026)	.108 (.033)	.115 (.020)	.122 (.032)

Population analysed: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data

Primary outcome: Clearance

Time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours. Mean (Standard Deviation). Unit: L/hour

Measure	Staccato Loxapine 0.625 mg n = 7	Staccato Loxapine 1.25 mg n = 8	Staccato Loxapine 2.5 mg n = 6	Staccato Loxapine 5 mg n = 7	Staccato Loxapine 10 mg n = 8
Value	56.2 (14.1)	55.9 (13.7)	61.1 (18.8)	53.8 (9.74)	78 (25.8)

Population analysed: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data

Adverse events

Time frame: Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Staccato Loxapine 0.625 mg	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Staccato Loxapine 1.25 mg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Staccato Loxapine 2.5 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Staccato Loxapine 5 mg	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Staccato Loxapine 10 mg	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Limitations and caveats (from the sponsor): Absolute bioavailability was not determined because loxapine for intravenous comparator was not available comercially in the US

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19915181Spyker DA, Munzar P, Cassella JV. Pharmacokinetics of loxapine following inhalation of a thermally generated aerosol in healthy volunteers. J Clin Pharmacol. 2010 Feb;50(2):169-79. doi: 10.1177/0091270009347866. Epub 2009 Nov 13.
Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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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.

Randall Stoltz, MD principal investigator

West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714

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 inhaled Loxapine 0.625 mg, inhaled Loxapine 1.25 mg and inhaled Loxapine 2.5 mg in people with Schizophrenia, 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 5 inclusion and 19 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 20 Nov 2018. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tmax (time frame: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours). The study lists 6 primary outcomes in all. 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 NCT00444028, 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 20 Nov 2018.