Conditions: ECG Effects
Keywords: Healthy subjects Opioid Transdermal ECG
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 328
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr arm 2: Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets arm 3: Naltrexone 50 mg tablets arm 4: Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets arm 5: Moxifloxacin 400-mg tablets

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Naltrexone tablet intervention 3: Placebos (for TDS and for naltrexone and for moxifloxacin) intervention 4: Moxifloxacin tablet
Intervention descriptions: intervention 1: Buprenorphine patch applied transdermally intervention 2: Naltrexone tablet; 1 tablet taken orally every 12 hours intervention 3: Matching placebos intervention 4: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17

Protocol document: