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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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.