NCT01999114

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

A Randomized, Triple-blind, Placebo- and Positive-Controlled, Parallel Group Study of the Effect of Buprenorphine Delivered by the Buprenorphine Transdermal System (BTDS) at Doses up to 80 mcg/Hour and Naltrexone on ECG Intervals in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• ECG Effects

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine patch applied transdermally
DRUG	Naltrexone tablet	Naltrexone tablet; 1 tablet taken orally every 12 hours
DRUG	Placebos (for TDS and for naltrexone and for moxifloxacin)	Matching placebos
DRUG	Moxifloxacin tablet	Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-12-03
• Last updated: 2018-11-05
• Results posted: 2018-11-05

Locations

1 site across 1 country: United States