Phase 4
Completed N=60
ADASUVE 2-dose Thorough QT/QTc Study
Healthy Volunteers
Source: ClinicalTrials.gov NCT01854710 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo — 4.04 msec
◆ Published Evidence
Emerging
15citations · ~1 / year
A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers.
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.
Linked Publications (2)
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A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers.
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A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo |
4.04 | — |
| SECONDARY QTc Versus Loxapine Concentration |
2.6 | — |
| SECONDARY Subjects With QTcI > 450 ms |
2; 2 | — |
| SECONDARY Subjects With QTcI > 480 ms |
0; 0 | — |
| SECONDARY Subjects With QTcI Increase > 30 ms From Baseline |
0; 1 | — |
| SECONDARY Subjects With QTcI Increase > 60 ms From Baseline |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01854710) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.