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

Purdue Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Buprenorphine transdermal patch; Drug: Avelox (moxifloxacin hydrochloride) tablet; Drug: Matching placebo transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01148537

BUP1011

Details and patient eligibility

About

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

Full description

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

Enrollment: 132 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 3 patient groups, including a placebo group

BTDS

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine transdermal patch

Placebo TDS

Placebo Comparator group

Description:

Matching placebo transdermal patches 5, 10, 20 and 2 \* 20.

Treatment:

Drug: Matching placebo transdermal patch

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin hydrochloride 400 mg tablets

Treatment:

Drug: Avelox (moxifloxacin hydrochloride) tablet