The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
Key facts
- Study ID
- NCT01148537
- Run by
- Purdue Pharma LP
- People needed
- 132
- Starts
- 2004-07-01
- Expected to finish
- 2004-12-01
- Last updated by the study team
- 2012-09-03
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- PPD Development, LP, Clinics — Austin, Texas, United States
Full record on ClinicalTrials.gov
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