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

NCT01148537 | Completed Phase 1 Results

• 1 other identifier: BUP1011
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy subjects; Opioid; Transdermal

Outcome Measures

Primary Outcomes (2)

• 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

  Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.

  Baseline to 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

  Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.

  Baseline to Day 13

Secondary Outcomes (6)

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

  Baseline to Day 6

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

  Baseline to Day 6

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

  Baseline to 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

  Baseline to 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

  Baseline to Day 6 and Day 13

Study Arms (3)

BTDS

EXPERIMENTAL

Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.

Drug: Buprenorphine transdermal patch

Placebo TDS

PLACEBO COMPARATOR

Matching placebo transdermal patches 5, 10, 20 and 2 \* 20.

Drug: Matching placebo transdermal patch

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin hydrochloride 400 mg tablets

Drug: Avelox (moxifloxacin hydrochloride) tablet

Interventions

Buprenorphine transdermal patch DRUG

Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h.

Also known as: Butrans™

BTDS

Matching placebo transdermal patch DRUG

Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20.

Placebo TDS

Avelox (moxifloxacin hydrochloride) tablet DRUG

Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13

Also known as: Avelox

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (1)

PPD Development, LP, Clinics

Austin, Texas, 78704, United States

Location

MeSH Terms

Interventions

Buprenorphine; Moxifloxacin; Tablets

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

BUP1011 is a safety study. The comparison of buprenorphine vs placebo on QTc (interval corrected for heart rate) values is the primary outcome.

Results Point of Contact

• Title: Executive Medical Director
• Organization: Purdue Pharma L.P.

800-733-1333

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: September 3, 2012
• Results First Posted: September 28, 2010

Record last verified: 2012-08

Locations

US (1)