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

NCT01999114 ↗

Phase 1 Completed 328 enrolled Purdue Pharma LP

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2012-03
Primary completion: 2012-10
Completion: 2012-10

Publications

Results Harris SC, Morganroth J, Ripa SR, Thorn MD, Colucci S. Effects of buprenorphine on QT intervals in healthy subjects: results of 2 randomized positive- and placebo-controlled trials. Postgrad Med. 2017 Jan;129(1):69-80. doi: 10.1080/00325481.2017.1270156.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	10 ug	Other
Subject	Buprenorphine	Other / unclassified	40 ug	Other
Subject	Buprenorphine	Other / unclassified	80 ug	Other
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Subject	Naltrexone	Small molecule	50 mg	Oral

Indications

No indication recorded.