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

NCT ID: NCT01148537

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2004-12-31

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).

Conditions

Healthy Volunteers

Keywords

Healthy subjects; Opioid; Transdermal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BTDS

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

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

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

Placebo TDS

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

Group Type: PLACEBO_COMPARATOR

Matching placebo transdermal patch

Intervention Type: DRUG

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

Moxifloxacin

Moxifloxacin hydrochloride 400 mg tablets

Group Type: ACTIVE_COMPARATOR

Avelox (moxifloxacin hydrochloride) tablet

Intervention Type: DRUG

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

Interventions

Buprenorphine transdermal patch

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

Intervention Type: DRUG

Matching placebo transdermal patch

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

Intervention Type: DRUG

Avelox (moxifloxacin hydrochloride) tablet

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

Intervention Type: DRUG

Other Intervention Names

Butrans™; Avelox

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Development, LP, Clinics

Austin, Texas, United States

Countries

United States

Other Identifiers

BUP1011

Identifier Type: -

Identifier Source: org_study_id