Phase 1
N=132
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01148537 ↗Enrolled (actual)
132
Serious AEs
0.8%
Results posted
Sep 2010
Primary outcome: Primary: 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 — 4.20; -1.71 QTci (msec) — p=< .001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Buprenorphine transdermal patch (Drug); Matching placebo transdermal patch (Drug); Avelox (moxifloxacin hydrochloride) tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- Dec 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4.20; -1.71 | < .001 sig |
| PRIMARY 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 |
4.17; -1.69 | < .001 sig |
| SECONDARY The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 |
-1.06; -1.46 | .770 |
| SECONDARY The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6 |
6.26; -1.38 | < .001 sig |
| SECONDARY The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 |
-0.37; -0.24; 6.31; -0.86 | .936 |
| SECONDARY The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13 |
8.13; -0.09; 6.55; -0.84 | < .001 sig |
| SECONDARY The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 |
-1.04; -2.33; 4.13; -1.88 | .427 |
| SECONDARY The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13 |
4.74; -2.12; 2.83; -1.85 | < .001 sig |
Summary
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
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).
Other protocol-specific exclusion/inclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01148537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.