The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers

Purdue Pharma LP132 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Healthy Volunteers

Interventions

Buprenorphine transdermal patchDRUG

Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h.

Matching placebo transdermal patchDRUG

Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20.

Avelox (moxifloxacin hydrochloride) tabletDRUG

Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PPD Development, LP, Clinics

Austin, Texas, United States

Outcomes

Primary Outcomes

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

Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.

Time frame: Baseline to Day 13

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

Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.

Time frame: Baseline to Day 13

Secondary Outcomes

The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6

QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.

Time frame: Baseline to Day 6

The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6

Data from ClinicalTrials.gov

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