A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

Phase 1 Completed 21 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.

Timeline

Start: 2011-09
Primary completion: 2011-12
Completion: 2011-12

Publications

Results Hulskotte EG, Bruce RD, Feng HP, Webster LR, Xuan F, Lin WH, O'Mara E, Wagner JA, Butterton JR. Pharmacokinetic interaction between HCV protease inhibitor boceprevir and methadone or buprenorphine in subjects on stable maintenance therapy. Eur J Clin Pharmacol. 2015 Mar;71(3):303-11. doi: 10.1007/s00228-014-1789-4. Epub 2015 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boceprevir	Small molecule	800 mg	Oral
Subject	Buprenorphine	Other / unclassified	8 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	24 mg	Subcutaneous
Subject	Methadone	Other / unclassified	20 mg	Oral
Subject	Methadone	Other / unclassified	150 mg	Oral
Subject	Naloxone	Small molecule	2 mg	Subcutaneous
Subject	Naloxone	Small molecule	6 mg	Subcutaneous

A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

Summary

Timeline

Publications

Drugs

Indications