Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
NCT ID: NCT01525628
Last Updated: 2016-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2012-04-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam
tolbutamide
CYP2C9 probe drug
midazolam
CYP3A probe drug
caffeine
CYP1A2 probe drug
BI 201335
HCV protease inhibitor
pegylated interferon
HCV treatment
BI 207127
HCV polymerase inhibitor
ribavirin
HCV treatment
Group B
Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam
BI 201335
HCV protease inhibitor
caffeine
CYP1A2 probe drug
tolbutamide
CYP2C9 probe drug
pegylated interferon
HCV treatment
BI 207127
HCV polymerase inhibitor
ribavirin
HCV treatment
midazolam
CYP3A probe drug
Group C
Effect of Dual oral DAAs on tenofovir
tenofovir
nucleoside analogue
BI 207127
HCV polymerase inhibitor
ribavirin
HCV treatment
BI 201335
HCV protease inhibitor
Group D
Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam
midazolam
CYP3A probe drug
BI 201335
HCV protease inhibitor
BI 207127
HCV polymerase inhibitor
ribavirin
HCV treatment
caffeine
CYP1A2 probe drug
tolbutamide
CYP2C9 probe drug
Group E
Effect of BI 201335 and BI 207127 on raltegravir
BI 201335
HCV protease inhibitor
ribavirin
HCV treatment
BI 207127
HCV polymerase inhibitor
Interventions
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midazolam
CYP3A probe drug
BI 201335
HCV protease inhibitor
tenofovir
nucleoside analogue
caffeine
CYP1A2 probe drug
tolbutamide
CYP2C9 probe drug
tolbutamide
CYP2C9 probe drug
midazolam
CYP3A probe drug
caffeine
CYP1A2 probe drug
pegylated interferon
HCV treatment
BI 201335
HCV protease inhibitor
BI 201335
HCV protease inhibitor
BI 207127
HCV polymerase inhibitor
BI 207127
HCV polymerase inhibitor
BI 201335
HCV protease inhibitor
BI 207127
HCV polymerase inhibitor
ribavirin
HCV treatment
ribavirin
HCV treatment
ribavirin
HCV treatment
pegylated interferon
HCV treatment
ribavirin
HCV treatment
caffeine
CYP1A2 probe drug
tolbutamide
CYP2C9 probe drug
BI 207127
HCV polymerase inhibitor
midazolam
CYP3A probe drug
BI 201335
HCV protease inhibitor
BI 207127
HCV polymerase inhibitor
ribavirin
HCV treatment
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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
Countries
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Other Identifiers
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2012-004102-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1241.27
Identifier Type: -
Identifier Source: org_study_id
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