Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

Completed · Phase 1

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01525628

Run by

Boehringer Ingelheim

People needed

72

Starts

2012-04-01

Expected to finish

2014-10-01

Last updated by the study team

2016-06-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
• Treatment naive or confirmed prior treatment relapse or partial response following treatment with interferon and ribavirin
• Age 18 to 70 years
• HCV RNA (Hepatitis C Virus RiboNucleic Acid) = 1,000 IU/mL at screening
• Liver biopsy or fibroscan to exclude cirrhosis

You may not qualify if…

• Hepatitis C Virus (HCV) infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
• Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
• Decompensated liver disease, or history of decompensated liver disease,
• Body weight < 40 or > 125 kg,
• Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
• Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
• Laboratory parameters disorders (thalassemia major, sickle cell anemia or glucose 6 phosphate dehydrogenase deficit)
• Hemoglobin < 12 g/dL for women and < 13 g/dL for men
• 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

Where it is running

• 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
• 1241.27.0003 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1241.27.0001 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 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
• 1241.27.0100 Boehringer Ingelheim Investigational Site — London, Ontario, Canada
• 1241.27.0300 Boehringer Ingelheim Investigational Site — Ottawa, Ontario, Canada
• 1241.27.0500 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
• 1241.27.4907 Boehringer Ingelheim Investigational Site — Cologne, Germany
• 1241.27.4901 Boehringer Ingelheim Investigational Site — Frankfurt am Main, Germany
• 1241.27.4903 Boehringer Ingelheim Investigational Site — Leipzig, Germany
• 1241.27.4906 Boehringer Ingelheim Investigational Site — Mainz, Germany

Full record on ClinicalTrials.gov

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