a study to evaluate the pharmacokinetic effect of sch 503034 (boceprevir) on methadone or buprenorphine/naloxone plasma concentrations (p08123)

Conditions: Hepatitis C Virus

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.


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