Boceprevir and Ucalm (St John&Apos;s Wort)
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: Boceprevir; St John's Wort
Intervention description: Boceprevir as Victrelis(r) 200mg capsules; Each Ucalm(r) tablet contains 300mg of St Johns Wort extract
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to look at whether taking a new medication for hepatitis C
      (boceprevir) together with a herbal remedy commonly used for the treatment of depression
      (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is
      taken on its own.

      Treatment of hepatitis C genotype-1, has recently been significantly improved with the
      addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this
      class of antiviral drugs and it is administered in combinations with other drugs to treat
      hepatitis C. One of the common side effects of treatment for hepatitis C is low mood
      (depression) for which treated patients may self-medicate with preparations containing St.
      Johns Wort (SJW).

      SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may
      result in a change in how both of these drugs usually work. It is therefore important to find
      out if the levels of boceprevir in the blood are significantly affected by taking SJW.

      The study aims to help us understand whether it will be safe to take SJW whilst being
      simultaneously treated for hepatitis C with boceprevir.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria within 28 days prior to day 0:

          1. The ability to understand and sign a written informed consent form, prior to
             participation in any screening procedures and must be willing to comply with all study
             requirements

          2. Male or non-pregnant, non-lactating females

          3. Between 18 to 65 years, inclusive

          4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.

          5. Women of childbearing potential (WOCBP), who are sexually active, must be using an
             adequate method of contraception to avoid pregnancy throughout the study and for a
             period of at least one month after the study in addition to the consistent and correct
             use of a condom. Examples of adequate methods of contraception for females in this
             trial are diaphragm with spermicide, substance and intra-uterine device. Hormonal
             contraceptives should not be considered a method of contraception and should be
             avoided if containing drospirenone.

          6. Willing to consent to their personal details being entered onto The Over volunteering
             Prevention Scheme (TOPS) database.

          7. Registered with a GP in the UK

          8. Willing to bring photo ID to each visit

        Exclusion Criteria:

        Subjects who meet any of the following exclusion criteria are not to be enrolled in this
        study.

          1. Any significant acute or chronic medical illness

          2. Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations

          3. Positive blood screen for hepatitis B and/or C antibodies

          4. Positive blood screen for HIV-1 and 2 antibodies

          5. Current or recent (within three months) gastrointestinal disease

          6. Clinically relevant alcohol or drug use (positive urine drug screen) or history of
             alcohol or drug use considered by the Investigator to be sufficient to hinder
             compliance with treatment, follow-up procedures or evaluation of adverse events.
             Smoking is permitted, but tobacco intake should remain consistent throughout the study

          7. Exposure to any investigational drug or placebo within three months of first dose of
             study drug (additional check to be made on TOPS www.tops.org.uk).

          8. Consumption of grapefruit or Seville oranges, or any grapefruit or Seville orange
             containing product within one week of first dose of study drug and for the duration of
             the study

          9. Use of any other drugs, including over-the-counter medications and herbal
             preparations, within two weeks prior to first dose of study drug, unless
             approved/prescribed by the Principal Investigator as known not to interact with study
             drugs (note OCPs containing drosperinone should be excluded)

         10. Females of childbearing potential without the use of effective non-hormonal birth
             control methods, or not willing to continue practising these birth control methods for
             at least 30 days after the end of the treatment period

         11. Previous allergy to any of the constituents of the pharmaceuticals administered in
             this trial