The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Buprenorphine transdermal patch; Matching placebo transdermal patch; Avelox (moxifloxacin hydrochloride) tablet
Intervention description: Buprenorphine transdermal patch 5, 10, 20, and 2 * 20 mcg/h.; Placebo transdermal patch to match BTDS 5, 10, 20, and 2 * 20.; Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13
Intervention MeSH terms: Moxifloxacin; Buprenorphine; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy subjects; Opioid; Transdermal

Summary:

      The purpose of this study is to examine the effect of buprenorphine on QT interval corrected
      for heart rate (QTc) in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 to 55 years of age, inclusive.

          -  Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≤ 30
             kg/m2.

          -  Healthy as determined by unremarkable medical history, physical examination, vital
             signs, laboratory evaluations, electrocardiogram (ECG), and a 24-hour screening ECG
             telemetry.

          -  Willing to refrain from strenuous exercise or contact sports during the study.

          -  Female subjects must be surgically sterile or at least 2 years postmenopausal, or
             using an effective contraceptive method (intrauterine device, hormonal contraceptive,
             or double-barrier method).

        Exclusion Criteria:

          -  Any clinically significant illness during the 30 days prior to randomization.

          -  Any history of allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic
             or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class of drugs.

          -  A clinically significant history of allergic reaction to wound dressings or bandages.

          -  Any medical or surgical conditions which might interfere with drug absorption
             (transdermal or gastrointestinal), distribution, metabolism, or excretion.

          -  Abnormalities on physical examination, vital signs, ECG, or clinical laboratory
             values, unless those abnormalities are judged to be clinically insignificant by the
             Investigator.

          -  Any cardiovascular disorders, including hypertension.

          -  Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.

          -  Any personal or family history of prolonged QT interval or disorders of cardiac
             rhythm.

          -  Abnormal cardiac condition denoted by any of the following:

          -  QT interval ≥ 450 milliseconds (msec).

          -  PR interval > 240 msec or ≤ 110 msec.

          -  Evidence of second- or third-degree atrioventricular (AV) block.

          -  Pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.5 mV).

          -  Evidence of ventricular preexcitation, complete left bundle branch block, right bundle
             branch block (RBBB), or incomplete RBBB.

          -  A resting heart rate outside the range of 50 to 85 beats per minute (bpm).

        Other protocol-specific exclusion/inclusion criteria may apply.