The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: ECG Effects

In brief

The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.

Key facts

Study ID

NCT01999114

Run by

Purdue Pharma LP

People needed

328

Starts

2012-03-01

Expected to finish

2012-10-01

Last updated by the study team

2018-11-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide written informed consent.
• Males and females aged 18 to 55, inclusive.
• Body weight ranging from 50 to 100 kilograms (kg) (110 to 220 lbs) and body mass index (BMI) ranging from 18 to 30 (kg/m2), inclusive.
• Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and resting 12-lead ECG.
• Females of child-bearing potential must be using an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must have been postmenopausal ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).
• Willing to eat the food supplied during the study.
• Willing to refrain from strenuous exercise during the entire study. Subjects will not begin a new exercise program nor participate in any unusually strenuous physical exertion.
• All 8 anatomical transdermal system (TDS) application sites (upper back, upper chest, upper outer arm, or lateral thorax) must be acceptable for study use.

You may not qualify if…

• Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating.
• Current or recent (within 5 years) history of drug or alcohol abuse.
• History or any current conditions that might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism or excretion.
• Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study.
• Known allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class drugs.
• Any history of frequent nausea or emesis regardless of etiology.
• Any history of seizures or head trauma with sequelae.
• Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
• Any significant illness during the 30 days preceding the initial dose in this study.
• Use of any medication including thyroid hormonal therapy (hormonal contraception and hormonal replacement therapy in the form of estrogen with or without progestin is allowed), vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose.
• Any personal or family history of prolonged QT interval or disorders of cardiac rhythm.
• Abnormal cardiac conditions including hypertension.
• Abnormal cardiac condition denoted by any of the following:
• QTcF interval > 450 milliseconds (msec)
• PR interval > 240 msec or QRS > 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 pre-excitation, complete left bundle branch block, right bundle branch block (RBBB), or incomplete RBBB
• With a resting heart rate outside the range of 45 to 85 beats per minute (bpm)
• Abnormalities on physical examination, vital signs, ECG, or clinical laboratory values, unless those abnormalities were judged clinically insignificant by the investigator.
• Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.
• Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
• Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and any time during study.
• History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test
• Blood or blood products donated within 30 days prior to study drug administration or anytime during the study.

Where it is running

• PPD Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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