drugset / Trial / NCT01582035
Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and in Europe for the treatment of chronic hepatitis C infected patients.
Timeline
- Start
- 2012-04
- Primary completion
- 2013-11
- Completion
- 2013-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TMC647055 | Small molecule | 500 mg | Oral |
| Subject | TMC647055 | Small molecule | 1000 mg | Oral |
| Subject | Telaprevir | Small molecule | 750 mg | Oral |
| Subject | Telaprevir | Small molecule | 1125 mg | Oral |
| Subject | Telaprevir | Small molecule | 1500 mg | Oral |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |
| Background | Ribavirin | Small molecule | 1200 mg | Oral |