Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: midazolam; BI 201335; tenofovir; caffeine; tolbutamide; tolbutamide; midazolam; caffeine; pegylated interferon; BI 201335; BI 201335; BI 207127; BI 207127; BI 201335; BI 207127; ribavirin; ribavirin; ribavirin; pegylated interferon; ribavirin; caffeine; tolbutamide; BI 207127; midazolam; BI 201335; BI 207127; ribavirin
Intervention description: CYP3A probe drug; HCV protease inhibitor; nucleoside analogue; CYP1A2 probe drug; CYP2C9 probe drug; CYP2C9 probe drug; CYP3A probe drug; CYP1A2 probe drug; HCV treatment; HCV protease inhibitor; HCV protease inhibitor; HCV polymerase inhibitor; HCV polymerase inhibitor; HCV protease inhibitor; HCV polymerase inhibitor; HCV treatment; HCV treatment; HCV treatment; HCV treatment; HCV treatment; CYP1A2 probe drug; CYP2C9 probe drug; HCV polymerase inhibitor; CYP3A probe drug; HCV protease inhibitor; HCV polymerase inhibitor; HCV treatment
Intervention MeSH terms: Tolbutamide; Interferons; Tenofovir; Ribavirin; Midazolam; Caffeine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their
      combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment
      naive or prior treatment relapse patients with chronic hepatitis C infection.
    

Eligibility criteria:

        Inclusion criteria:

          1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to
             screening

          2. Treatment naive or confirmed prior treatment relapse or partial response following
             treatment with interferon and ribavirin

          3. Age 18 to 70 years

          4. HCV RNA (Hepatitis C Virus RiboNucleic Acid) = 1,000 IU/mL at screening

          5. Liver biopsy or fibroscan to exclude cirrhosis

        Exclusion criteria:

          1. Hepatitis C Virus (HCV) infection of mixed genotype; Hepatitis B Virus (HBV) or Human
             Immunodeficiency Virus (HIV) co-infection

          2. Evidence of acute or chronic liver disease due to causes other than chronic HCV
             infection,

          3. Decompensated liver disease, or history of decompensated liver disease,

          4. Body weight < 40 or > 125 kg,

          5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary
             disease, history or evidence of retinopathy or clinically significant ophthalmological
             disorder

          6. Pre-existing psychiatric condition that could interfere with the subject's
             participation in and completion of the study

          7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or glucose 6
             phosphate dehydrogenase deficit)

          8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men

          9. Patients who have been previously treated with at least one dose of any antiviral or
             immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV
             infection