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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 na´ve 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 201335

C24hr 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, K├Âln, 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

Page last updated: August 23, 2015

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