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

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.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 36, inclusive
* Reliable participation in a methadone maintenance or buprenorphine maintenance or buprenorphine/naloxone maintenance program for at least two (2) months prior to Day 1.
* Is receiving once daily oral dose of methadone therapy at a stable

individualized dose for at least 4 weeks, receiving once

daily buprenorphine dose at a stable individualized dose for at 4 weeks with, if on buprenorphine only therapy, naloxone added for at least 2 weeks prior to Day 1.

* 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
* Vital signs within normal range
* Clinical laboratory tests within normal range
* Women who are postmenopausal, surgically sterilized, or premenopausal and use a medically-accepted method of contraception.

Exclusion Criteria:

* Pregnancy, breast feeding, or intention to become pregnant or father a child while on study or within 3 months after end of trial
* History or presence of inflammatory bowel disease, ulcers, or gastrointestinal or rectal bleeding
* History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
* History of pancreatic injury or pancreatitis
* History or presence of liver disease or liver injury
* History or presence of impaired renal function
* History of urinary obstruction or difficulty in voiding
* History of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial
* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* Positive screen for drugs with a high potential for abuse such as cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, or opiates/opioids
* Excessive use of alcohol in the 2 weeks prior to Day -1, defined as greater than 3 glasses of alcoholic beverages (1 is approximately equivalent to: beer \[284 mL/10 oz\], wine

  \[125 mL/4 oz\], or distilled spirits \[25 mL/1 oz\]) per day.
* Blood donation in the past 60 days
* Previous administration of SCH 503034 (boceprevir)
* Current participation in another clinical study or participation in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline
* Study staff personnel or family members of the study staff personnel
* Demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) that, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial
* History of malignancy within 5 years from Screening
* Consumption of excessive amounts (equivalent to \> 6 cups of brewed coffee/day) of coffee, tea, cola or other caffeinated beverages
* Receipt of any of the following more recently than the washout period prior to Baseline: inhibitors or inducers of cytochrome (CYP) P450, CYP2B6, CYP3A4, and CYP2D6; or oral contraceptives containing drospirenone