Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: midazolam (Drug); BI 201335 (Drug); tenofovir (Drug); caffeine (Drug); tolbutamide (Drug); tolbutamide (Drug); midazolam (Drug); caffeine (Drug); pegylated interferon (Drug); BI 201335 (Drug); BI 201335 (Drug); BI 207127 (Drug); BI 207127 (Drug); BI 201335 (Drug); BI 207127 (Drug); ribavirin (Drug); ribavirin (Drug); ribavirin (Drug); pegylated interferon (Drug); ribavirin (Drug); caffeine (Drug); tolbutamide (Drug); BI 207127 (Drug); midazolam (Drug); BI 201335 (Drug); BI 207127 (Drug); ribavirin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
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.
Clinical Details
Official title: A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the Pharmacokinetics of Tenofovir, Raltegravir, Caffeine (the Probe Drug Substrate for CYP1A2), Tolbutamide (the Probe Drug Substrate for CYP2C9) and Midazolam (the Probe Drug Substrate for CYP3A4) in Treatment naïve Patients and Prior Treatment Relapse or Partial Responder Patients With Genotype 1 Chronic Hepatitis C Infection
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cmax BI 201335C24hr BI 201335 AUC 0-24hr BI 201335 AUC 0-24h BI 201335 Cmax BI 207127 C6h BI 207127 AUC0-6h BI 207127 Cmax Midazolam AUC 0-24h Midazolam Cmax Caffeine AUC 0-24h Caffeine Cmax Tenofovir C24h Tenofovir AUC 0-24hr Tenofovir Cmax Raltegravir C12h Raltegravir AUC 0-12h Raltegravir C12 hr BI 207127 AUC 0-12 hr BI 207127 Cmax Tolbutamide AUC 0-24 hr Tolbutamide
Secondary outcome: Sustained Virological Response
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
1241.27.4901 Boehringer Ingelheim Investigational Site, Frankfurt am Main, Germany
1241.27.4907 Boehringer Ingelheim Investigational Site, Köln, Germany
1241.27.4903 Boehringer Ingelheim Investigational Site, Leipzig, Germany
1241.27.4906 Boehringer Ingelheim Investigational Site, Mainz, Germany
1241.27.0200 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada
1241.27.0600 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada
1241.27.0700 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada
1241.27.0400 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada
1241.27.0006 Boehringer Ingelheim Investigational Site, La Mesa, California, United States
1241.27.0005 Boehringer Ingelheim Investigational Site, Rockville, Maryland, United States
1241.27.0004 Boehringer Ingelheim Investigational Site, Marlton, New Jersey, United States
1241.27.0100 Boehringer Ingelheim Investigational Site, London, Ontario, Canada
1241.27.0300 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada
1241.27.0003 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States
1241.27.0500 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada
1241.27.0001 Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States
Additional Information
Starting date: April 2012
Last updated: February 4, 2015
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