# Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

> **NCT00947349** · PHASE2 · COMPLETED · sponsor: **Boehringer Ingelheim** · enrollment: 22 (actual)

## Conditions studied

- Hepatitis C
- Pharmacokinetics

## Interventions

- **DRUG:** ribavirin (RBV)
- **DRUG:** pegylated interferon (PegIFN) alfa-2a
- **DRUG:** pegylated interferon (PegIFN) alfa-2a
- **DRUG:** ribavirin (RBV)
- **DRUG:** BI 201335 NA low placebo
- **DRUG:** pegylated interferon (PegIFN) alfa-2a
- **DRUG:** ribavirin (RBV)
- **DRUG:** BI 201335 NA high
- **DRUG:** BI 201335 NA low
- **DRUG:** BI 201335 NA high placebo
- **DRUG:** BI 201335 NA high
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00947349
- **Lead sponsor:** Boehringer Ingelheim
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-07
- **Primary completion:** 2011-08
- **Final completion:** 2011-08
- **Target enrollment:** 22 (ACTUAL)
- **Last updated:** 2015-07-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00947349

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00947349, "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT00947349. Licensed CC0.

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