CardiotoxicityPhase 1NCT00543062

Staccato Prochlorperazine Thorough QT/QTc

A Phase 1 study testing Inhaled prochlorperazine 5 mg, Inhaled prochlorperazine 10 mg and Oral moxifloxacin in people with Cardiotoxicity, 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

To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cardiotoxicity
What is being tested?: Inhaled prochlorperazine 5 mg, Inhaled prochlorperazine 10 mg and Oral moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Dec 2007
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female subjects between the ages of 18 to 65 years, inclusive.
Body mass index (BMI) ≥21 and ≤30.
Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 3-day period and 3 consecutive 2-day periods.
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 in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.

Who cannot join

Subjects who regularly consume large amounts of xanthine-containing substances must be excluded.
Subjects who have taken prescription or nonprescription medication within 5 days of Treatment Period 1 must be excluded.
Subjects who have had an acute illness within the last 5 days of Treatment Period 1 must be excluded.
Subjects who have smoked tobacco within the last year must be excluded.
Subjects who have a history of HIV positivity must be excluded.
Subjects who have a history of allergy or intolerance to prochlorperazine or phenothiazines must be excluded.

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Subjects who have a history of contraindication to anticholinergics must be excluded.
Subjects who have a history of pheochromocytoma, seizure disorder, Parkinson's disease, or Restless Leg Syndrome must be excluded.
Subjects who have an ECG abnormality must be excluded.
Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
Subjects who have a history of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded.
Subjects who have a history of asthma or chronic obstructive lung disease must be excluded.
Subjects who have hypotension (systolic ≤90 mmHg, diastolic ≤50 mmHg), or hypertension (systolic ≥140 mmHg, diastolic blood pressure ≥90 mmHg) must be excluded.
Subjects who test positive for alcohol or have a positive urine drug screen must be excluded.
Female subjects who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
Subjects who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.
Subjects who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion present undue risk to the subject or may confound the interpretation of study results must be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit Inc.
Evansville, Indiana, 47714

Other trials in United States

About this study

Official title: Thorough QT/QTc Study of Staccato® Prochlorperazine for Inhalation in Healthy Volunteers

To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.

Read the detailed description

The planned study is a single dose, double-blind, double-dummy, active and placebo controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral moxifloxacin), and placebo.

Conditions: Cardiotoxicity
Being tested: Inhaled placebo, Oral placebo, Inhaled prochlorperazine 5 mg, Inhaled prochlorperazine 10 mg, Oral moxifloxacin
Keywords: Inhaled prochlorperazine, Thorough Qt/QTc,
Medical subject headings: Cardiotoxicity

What participants receive

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

Inhaled placeboDrug
Inhaled Staccato placebo (0 mg)
Oral placeboDrug
Oral placebo (identical to 400 mg moxifloxacin)
Inhaled prochlorperazine 5 mgDrug
Also called ADASUVE
Staccato prochlorperazine 5 mg, single dose
Inhaled prochlorperazine 10 mgDrug
Also called ADASUVE
Inhaled prochlorperazine 10 mg, single dose
Oral moxifloxacinDrug
Oral moxifloxacin 400 mg, si/ngle dose

Study groups in NCT00543062
Study group	Role	What they receive
Treatment Sequence ABCD	Other	Treatment Sequence ABCD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg Receives: Drug: Inhaled placebo; Drug: Oral placebo; Drug: Inhaled prochlorperazine 5 mg; Drug: Inhaled prochlorperazine 10 mg; Drug: Oral moxifloxacin
Treatment Sequence BDAC	Other	Treatment Sequence BDAC where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg Receives: Drug: Inhaled placebo; Drug: Oral placebo; Drug: Inhaled prochlorperazine 5 mg; Drug: Inhaled prochlorperazine 10 mg; Drug: Oral moxifloxacin
Treatment Sequence CABD	Other	Treatment Sequence CABD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg Receives: Drug: Inhaled placebo; Drug: Oral placebo; Drug: Inhaled prochlorperazine 5 mg; Drug: Inhaled prochlorperazine 10 mg; Drug: Oral moxifloxacin
Treatment Sequence DCBA	Other	Treatment Sequence DCBA where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg Receives: Drug: Inhaled placebo; Drug: Oral placebo; Drug: Inhaled prochlorperazine 5 mg; Drug: Inhaled prochlorperazine 10 mg; Drug: Oral moxifloxacin

What is being measured

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

Maximum Effect of Inhaled Prochlorperazine on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for treatment at 11 post-inhalation times.
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr

Secondary outcomes (5)

QTcI Versus Prochlorperazine Concentration
QTcI @ median prochlorperazine concentration (3.75 mcg/mL) based on linear and nonlinear regression of QTcI versus time matched serum prochlorperazine concentrations
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI > 450 ms
Numbers and Percents of Subjects with QTcI exceeding 450 ms
Measured: 24 hours
Numbers and % of Subjects With QTcI > 480 ms
Numbers and Percents of Subjects with QTcI exceeding 480 ms at any of the outcome measure time points
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI Change > 30 ms
Numbers and Percents of Subjects with QTcI increase from baseline exceeding 30 ms at any of the outcome measure time points
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI Change > 60 ms
Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms at any of the outcome measure time points
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr

Timeline

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

Oct 2007Dec 2007

First posted12 Oct 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.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CardiotoxicityStudies 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: Crossover
Model description: Female and male subjects in approximately equal numbers were randomly assigned (1:1:1:1) to receive the 4 treatment sequences
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00543062
Sponsor's protocol ID: AMDC-001-102
Other IDs: 20 July 2007
Status last verified: Nov 2008
First submitted: 10 Oct 2007
Last updated: 11 Mar 2019
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

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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Thorough QT/QTc Study of Staccato® Prochlorperazine for Inhalation in Healthy Volunteers
ClinicalTrials.gov ID: NCT00543062
Acronym / sponsor ID: AMDC-001-102
Conditions: Cardiotoxicity
Keywords: Inhaled prochlorperazine, Thorough Qt/QTc,
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Alexza Pharmaceuticals, Inc.
Study start: Oct 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 12 Oct 2007 (estimated)
Results: Posted 11 Mar 2019

Clinical summary

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

To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Female and male subjects in approximately equal numbers were randomly assigned (1:1:1:1) to receive the 4 treatment sequences

Arm	Type	Receives
Treatment Sequence ABCD	Other	Drug: Inhaled placebo, Drug: Oral placebo, Drug: Inhaled prochlorperazine 5 mg, Drug: Inhaled prochlorperazine 10 mg, Drug: Oral moxifloxacinTreatment Sequence ABCD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg
Treatment Sequence BDAC	Other	Drug: Inhaled placebo, Drug: Oral placebo, Drug: Inhaled prochlorperazine 5 mg, Drug: Inhaled prochlorperazine 10 mg, Drug: Oral moxifloxacinTreatment Sequence BDAC where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg
Treatment Sequence CABD	Other	Drug: Inhaled placebo, Drug: Oral placebo, Drug: Inhaled prochlorperazine 5 mg, Drug: Inhaled prochlorperazine 10 mg, Drug: Oral moxifloxacinTreatment Sequence CABD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg
Treatment Sequence DCBA	Other	Drug: Inhaled placebo, Drug: Oral placebo, Drug: Inhaled prochlorperazine 5 mg, Drug: Inhaled prochlorperazine 10 mg, Drug: Oral moxifloxacinTreatment Sequence DCBA where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male and female subjects between the ages of 18 to 65 years, inclusive.
Body mass index (BMI) ≥21 and ≤30.
Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 3-day period and 3 consecutive 2-day periods.
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 in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.

Key exclusion criteria (18 listed)

Subjects who regularly consume large amounts of xanthine-containing substances must be excluded.
Subjects who have taken prescription or nonprescription medication within 5 days of Treatment Period 1 must be excluded.
Subjects who have had an acute illness within the last 5 days of Treatment Period 1 must be excluded.
Subjects who have smoked tobacco within the last year must be excluded.
Subjects who have a history of HIV positivity 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
Inhaled placeboInhaled Staccato placebo (0 mg)	Drug	Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CABD, Treatment Sequence DCBA
Oral placeboOral placebo (identical to 400 mg moxifloxacin)	Drug	Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CABD, Treatment Sequence DCBA
Inhaled prochlorperazine 5 mgAlso: ADASUVEStaccato prochlorperazine 5 mg, single dose	Drug	Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CABD, Treatment Sequence DCBA
Inhaled prochlorperazine 10 mgAlso: ADASUVEInhaled prochlorperazine 10 mg, single dose	Drug	Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CABD, Treatment Sequence DCBA
Oral moxifloxacinOral moxifloxacin 400 mg, si/ngle dose	Drug	Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CABD, Treatment Sequence DCBA

Primary outcome

Maximum Effect of Inhaled Prochlorperazine on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for treatment at 11 post-inhalation times.

5 secondary outcomes

QTcI Versus Prochlorperazine Concentration
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI > 450 ms
Time frame: 24 hours
Numbers and % of Subjects With QTcI > 480 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI Change > 30 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI Change > 60 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr

Results and safety

Results posted to the registry on 11 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ABCD	12	10
Treatment Sequence BDAC	12	11
Treatment Sequence CABD	12	9
Treatment Sequence DCBA	12	11

Primary outcome: Maximum Effect of Inhaled Prochlorperazine on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo

Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr. Least squares mean (90% Confidence Interval). Unit: milliseconds

Measure	Placebo+Inhaled Prochlorperazine 5 mg Crossover Subjects n = 42	Placebo+Inhaled Prochlorperazine 10 mg Crossover Subjects n = 42
Value	5.493 (2.635 to 8.351)	5.229 (2.405 to 8.052)

Population analysed: QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between prochlorperazine and placebo exposures per ICH Guideline E14 for a thorough QT/QTc study.

5 secondary outcomes are reported in the full results.

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 45 (0%)	4 of 45 (8.9%)	0 of 45
Inhaled Prochlorperazine 5 mg	0 of 44 (0%)	24 of 44 (54.5%)	0 of 44
Inhaled Prochlorperazine 10 mg	0 of 46 (0%)	29 of 46 (63%)	0 of 46
Oral Moxifloxacin 400 mg	0 of 43 (0%)	4 of 43 (9.3%)	0 of 43

Limitations and caveats (from the sponsor): The use of healthy subjects precludes observation of drug-induced QTc prolongation in a population with additional factors predisposing to TdP. Subjects with respiratory disease were excluded.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 R Stoltz, MD principal investigator

Covance GFI Research, Evansville, IN 47714

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 18 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 11 Mar 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 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 11 Mar 2019). 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?

Maximum Effect of Inhaled Prochlorperazine on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo (time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr). 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 NCT00543062.

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 11 Mar 2019.