A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Intervention: boceprevir; methadone; buprenorphine/naloxone
Intervention description: boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7; methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8; buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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