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

Information source: Purdue Pharma LP
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

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

Phase: Phase 1

Status: Completed

Sponsored by: Purdue Pharma LP

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13

The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13

The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13

The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

PPD Development, LP, Clinics, Austin, Texas 78704, United States
Additional Information

Product Information

Starting date: July 2004
Last updated: August 27, 2012

Page last updated: August 23, 2015

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