Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam arm 2: Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam arm 3: Effect of Dual oral DAAs on tenofovir arm 4: Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam arm 5: Effect of BI 201335 and BI 207127 on raltegravir

Interventions: intervention 1: midazolam intervention 2: BI 201335 intervention 3: tenofovir intervention 4: caffeine intervention 5: tolbutamide intervention 6: tolbutamide intervention 7: midazolam intervention 8: caffeine intervention 9: pegylated interferon intervention 10: BI 201335 intervention 11: BI 201335 intervention 12: BI 207127 intervention 13: BI 207127 intervention 14: BI 201335 intervention 15: BI 207127 intervention 16: ribavirin intervention 17: ribavirin intervention 18: ribavirin intervention 19: pegylated interferon intervention 20: ribavirin intervention 21: caffeine intervention 22: tolbutamide intervention 23: BI 207127 intervention 24: midazolam intervention 25: BI 201335 intervention 26: BI 207127 intervention 27: ribavirin
Intervention descriptions: intervention 1: CYP3A probe drug intervention 2: HCV protease inhibitor intervention 3: nucleoside analogue intervention 4: CYP1A2 probe drug intervention 5: CYP2C9 probe drug intervention 6: CYP2C9 probe drug intervention 7: CYP3A probe drug intervention 8: CYP1A2 probe drug intervention 9: HCV treatment intervention 10: HCV protease inhibitor intervention 11: HCV protease inhibitor intervention 12: HCV polymerase inhibitor intervention 13: HCV polymerase inhibitor intervention 14: HCV protease inhibitor intervention 15: HCV polymerase inhibitor intervention 16: HCV treatment intervention 17: HCV treatment intervention 18: HCV treatment intervention 19: HCV treatment intervention 20: HCV treatment intervention 21: CYP1A2 probe drug intervention 22: CYP2C9 probe drug intervention 23: HCV polymerase inhibitor intervention 24: CYP3A probe drug intervention 25: HCV protease inhibitor intervention 26: HCV polymerase inhibitor intervention 27: HCV treatment

Protocol document: