ADASUVE 2-dose Thorough QT/QTc Study
Condition: Healthy Volunteers
Intervention: ADASUVE 10 mg 2 doses 2 hours apart; Inhaled Placebo; Oral moxifloxacin 400 mg; Oral placebo
Intervention description: Inhaled loxapine 10 mg 2 doses 2 hours apart; Staccato placebo via inhalation x 2 at 2 hours apart; Oral moxifloxacin 400 mg single dose; Oral capsule identical in appearance to moxifloxacin
Intervention MeSH terms: Moxifloxacin; Loxapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADASUVE; inhaled loxapine; thorough QT/QTc study

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.
    

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.