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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.