Clinical trial NCT01148537: The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy subjects
Opioid
Transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).

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.

Primary outcomes:
measure: The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13
timeFrame: Baseline to Day 13
measure: The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13
timeFrame: Baseline to Day 13
Secondary outcomes:
measure: The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
timeFrame: Baseline to Day 6
measure: The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
timeFrame: Baseline to Day 6
measure: The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
timeFrame: Baseline to Day 6 and Day 13
measure: The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
timeFrame: Baseline to Day 6 and Day 13
measure: The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
timeFrame: Baseline to Day 6 and Day 13
measure: The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
timeFrame: Baseline to Day 6 and Day 13
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP, Clinics
state: Texas
Study officials:
References: