The Boceprevir and Sildenafil Pharmacokinetics Study
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: Sildenafil and Boceprevir
Intervention description: 25mg once/800mg three times a day
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      This is a healthy volunteer study looking at the interactions between two drugs: boceprevir
      and sildenafil.

      New drugs are being developed to treat people with the chronic viral infection hepatitis C.
      Very little is know how these new treatments interact with other medications such as the
      drugs used to treat erectile dysfunction.

      The purpose of this study is to look at levels of both a new hepatitis C drug called
      boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they
      affect the blood levels of each other when given separately and together.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Subjects in good health upon medical history, physical exam, and laboratory testing
             and BMI <32.

          -  Subjects who are heterosexually active must use two forms of barrier contraception
             (e.g., condom with spermicide) during heterosexual intercourse, from screening through
             completion of the study including 10 days following last dose of study drug.

          -  Have no serologic evidence of HIV or HCV infection through antibody testing at
             screening.

          -  Have screening laboratory results (haematology, chemistry) that fall within the normal
             range of the central laboratory's reference ranges unless the results have been
             determined by the Investigator to have no clinical relevance

        Exclusion Criteria:

          -  Any serious or active medical or psychiatric illness which, in the opinion of the
             Investigator, would interfere with subject treatment, assessment, or compliance with
             the protocol. This would include any active clinically significant renal, cardiac,
             hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease),
             immunodeficiency disorders, active infection, or malignancy.

          -  Previous participation in an investigational trial involving administration of any
             investigational compound within 1 month prior to the study screening.

          -  Clinically relevant alcohol or drug use (positive 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.

          -  Any medication taken listed in protocol including over-the-counter medications and
             herbal products within 21 days of commencing study drug dosing with the exception of
             vitamins and/or paracetamol. When a concomitant medication is necessary, this will be
             reviewed by the Investigator and if not contraindicated, may be continued at the same
             dose and frequency during the study period.

          -  History of drug sensitivity or drug allergy which in the opinion of the investigator
             may put the subject at increased risk of drug reactions during the study.

          -  Subjects with female partners who are pregnant will not be allowed to enter the study