Healthy VolunteersPhase 4NCT01854710
ADASUVE 2-dose Thorough QT/QTc Study
A Phase 4 study testing ADASUVE 10 mg 2 doses 2 hours apart and Oral moxifloxacin 400 mg in people with Healthy Volunteers, run by Alexza Pharmaceuticals, Inc. at 1 site in Netherlands.
Trial summary
Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control 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
- Healthy Volunteers
- What is being tested?
- ADASUVE 10 mg 2 doses 2 hours apart and Oral moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 4
- 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) ≥18 and ≤32.
- Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 4-day period and 2 consecutive 3-day periods.
- Subjects who speak, read, and understand English and/or Dutch and are willing and able to provide written informed consent on an IEC approved form prior to the initiation of any study procedures.
- Subjects who are in good general health prior to study participation
- Female or male participants who agree to use a medically acceptable and effective birth control method
Who cannot join
- Subjects who regularly consume large amounts of xanthine-containing substances (≥ 5 cups of coffee/day).
- Subjects who have taken prescription or nonprescription medication within 5 days of Visit 2.
- Subjects who have had an acute illness within the last 5 days of Visit 2.
- Subjects who have smoked tobacco within the last 30 days or who have a positive cotinine test.
- Subjects who have a history of HIV, anti-HCV or HbsAg positivity.
- Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-IV.
Show all 16Show fewer
- Subjects who test positive for alcohol or have a positive urine drug screen.
- Subjects who have a history of allergy or intolerance to loxapine or amoxapine or history of bronchospasm following inhaled loxapine treatment.
- Subjects who have an ECG abnormality.
- Subjects who have hypotension, or hypertension.
- Subjects who have a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure, transient ischemic attack, history of convulsions or other neurological disorder.
- Subjects who have a current history of asthma, chronic obstructive lung disease, or any other lung disease associated with bronchospasm.
- Subjects who use medications to treat airways disease, such as asthma or COPD.
- Subjects who have any acute respiratory signs/symptoms (e.g., wheezing).
- Female subjects who have a positive pregnancy test at screening or at admission to any of the treatment visits, or are breastfeeding.
- Subjects who have received an investigational drug within 60 days prior to the Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thorough QT/QTc Study of 2 Doses of ADASUVE® in Healthy Volunteers
Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.
Read the detailed description
It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.
The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec
- Conditions
- Healthy Volunteers
- Being tested
- ADASUVE 10 mg 2 doses 2 hours apart, Inhaled Placebo, Oral moxifloxacin 400 mg, Oral placebo
- Keywords
- ADASUVE, inhaled loxapine, thorough QT/QTc study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADASUVE 10 mg 2 doses 2 hours apartDrug
Also called Staccato Loxapine
Inhaled loxapine 10 mg 2 doses 2 hours apart
Inhaled PlaceboDrug
Staccato placebo via inhalation x 2 at 2 hours apart
Oral moxifloxacin 400 mgDrug
Also called AVELOX
Oral moxifloxacin 400 mg single dose
Oral placeboDrug
Oral capsule identical in appearance to moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence ABC | Other | Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo Receives: Drug: ADASUVE 10 mg 2 doses 2 hours apart; Drug: Inhaled Placebo; Drug: Oral moxifloxacin 400 mg; Drug: Oral placebo |
| Treatment sequence ACB | Other | Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo Receives: Drug: ADASUVE 10 mg 2 doses 2 hours apart; Drug: Inhaled Placebo; Drug: Oral moxifloxacin 400 mg; Drug: Oral placebo |
| Treatment sequence BCA | Other | Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo Receives: Drug: ADASUVE 10 mg 2 doses 2 hours apart; Drug: Inhaled Placebo; Drug: Oral moxifloxacin 400 mg; Drug: Oral placebo |
| Treatment sequence BAC | Other | Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo Receives: Drug: ADASUVE 10 mg 2 doses 2 hours apart; Drug: Inhaled Placebo; Drug: Oral moxifloxacin 400 mg; Drug: Oral placebo |
| Treatment sequence CAB | Other | Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo Receives: Drug: ADASUVE 10 mg 2 doses 2 hours apart; Drug: Inhaled Placebo; Drug: Oral moxifloxacin 400 mg; Drug: Oral placebo |
| Treatment sequence CBA | Other | Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo Receives: Drug: ADASUVE 10 mg 2 doses 2 hours apart; Drug: Inhaled Placebo; Drug: Oral moxifloxacin 400 mg; Drug: Oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Effect of ADASUVE 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 ADASUVE treatment at 12 post-inhalation times.
Measured: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Secondary outcomes (5)
QTc Versus Loxapine Concentration
QTc @ Cmax based on linear and nonlinear regression of QTcI versus time matched serum loxapine concentrations
Measured: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI > 450 ms
Numbers of Subjects with QTcI > 450 ms at any time point
Measured: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI > 480 ms
Numbers of Subjects with QTcI > 480 ms (or 500 ms) at any time point
Measured: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI Increase > 30 ms From Baseline
Numbers of Subjects with QTcI Increase > 30 ms from Baseline at any time point
Measured: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI Increase > 60 ms From Baseline
Numbers of Subjects with QTcI Increase > 60 ms From Baseline at any time point
Measured: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
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 (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, randomized, double-blind, double-dummy, 2-dose, 3-period, active- and placebo-controlled, crossover QT/QTc and pharmacokinetic (PK) study of ADASUVE in healthy volunteers. All dosing and treatment-day follow-up in the study was conducted in the clinical research unit (CRU)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Teresa Nunes, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854710
- Sponsor's protocol ID
- AMDC-204-407
- Other IDs
- 204-407
- Status last verified
- Jul 2013
- First submitted
- 8 May 2013
- Last updated
- 18 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Publications
Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Nov;53(11):963-71. doi: 10.5414/CP202457.
PubMed 26501204Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Oct 7. doi: 10.5414/CP202457. Online ahead of print.
PubMed 26445139
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thorough QT/QTc Study of 2 Doses of ADASUVE® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01854710
- Acronym / sponsor ID
- AMDC-204-407
- Conditions
- Healthy Volunteers
- Keywords
- ADASUVE, inhaled loxapine, thorough QT/QTc study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 18 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.
Detailed description
It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.
The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Single-center, randomized, double-blind, double-dummy, 2-dose, 3-period, active- and placebo-controlled, crossover QT/QTc and pharmacokinetic (PK) study of ADASUVE in healthy volunteers. All dosing and treatment-day follow-up in the study was conducted in the clinical research unit (CRU)
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence ABC | Other | Drug: ADASUVE 10 mg 2 doses 2 hours apart, Drug: Inhaled Placebo, Drug: Oral moxifloxacin 400 mg, Drug: Oral placeboTreatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo |
| Treatment sequence ACB | Other | Drug: ADASUVE 10 mg 2 doses 2 hours apart, Drug: Inhaled Placebo, Drug: Oral moxifloxacin 400 mg, Drug: Oral placeboTreatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo |
| Treatment sequence BCA | Other | Drug: ADASUVE 10 mg 2 doses 2 hours apart, Drug: Inhaled Placebo, Drug: Oral moxifloxacin 400 mg, Drug: Oral placeboTreatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo |
| Treatment sequence BAC | Other | Drug: ADASUVE 10 mg 2 doses 2 hours apart, Drug: Inhaled Placebo, Drug: Oral moxifloxacin 400 mg, Drug: Oral placeboTreatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo |
| Treatment sequence CAB | Other | Drug: ADASUVE 10 mg 2 doses 2 hours apart, Drug: Inhaled Placebo, Drug: Oral moxifloxacin 400 mg, Drug: Oral placeboTreatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo |
| Treatment sequence CBA | Other | Drug: ADASUVE 10 mg 2 doses 2 hours apart, Drug: Inhaled Placebo, Drug: Oral moxifloxacin 400 mg, Drug: Oral placeboTreatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo |
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) ≥18 and ≤32.
- Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 4-day period and 2 consecutive 3-day periods.
- Subjects who speak, read, and understand English and/or Dutch and are willing and able to provide written informed consent on an IEC approved form prior to the initiation of any study procedures.
- Subjects who are in good general health prior to study participation
Key exclusion criteria (16 listed)
- Subjects who regularly consume large amounts of xanthine-containing substances (≥ 5 cups of coffee/day).
- Subjects who have taken prescription or nonprescription medication within 5 days of Visit 2.
- Subjects who have had an acute illness within the last 5 days of Visit 2.
- Subjects who have smoked tobacco within the last 30 days or who have a positive cotinine test.
- Subjects who have a history of HIV, anti-HCV or HbsAg positivity.
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 |
|---|---|---|
| ADASUVE 10 mg 2 doses 2 hours apartAlso: Staccato LoxapineInhaled loxapine 10 mg 2 doses 2 hours apart | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
| Inhaled PlaceboStaccato placebo via inhalation x 2 at 2 hours apart | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
| Oral moxifloxacin 400 mgAlso: AVELOXOral moxifloxacin 400 mg single dose | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
| Oral placeboOral capsule identical in appearance to moxifloxacin | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
Primary outcome
Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
Time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 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 ADASUVE treatment at 12 post-inhalation times.
5 secondary outcomes
QTc Versus Loxapine Concentration
Time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI > 450 ms
Time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI > 480 ms
Time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI Increase > 30 ms From Baseline
Time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Subjects With QTcI Increase > 60 ms From Baseline
Time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26501204Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Nov;53(11):963-71. doi: 10.5414/CP202457.
- Derived from this study: PubMed 26445139Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Oct 7. doi: 10.5414/CP202457. Online ahead of print.
- Individual participant dataSharing planned: No. 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.
Teresa Nunes, MD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADASUVE 10 mg 2 doses 2 hours apart and Oral moxifloxacin 400 mg in people with Healthy Volunteers, 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 6 inclusion and 16 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 18 Oct 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 Oct 2017). 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 ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo (time frame: Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 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 NCT01854710, which also lists 2 linked publications.
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 18 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.