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.
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
