drugset / Trial / NCT02268760
Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
RandomizedParallel-groupDouble-blindTreatment
Summary
To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW 1. In rising single doses 2. With and without a 64 g fat breakfast at one selected dose
Timeline
- Start
- 2001-06
- Primary completion
- 2001-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CILUPREVIR | Small molecule | 5 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 20 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 60 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 100 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 200 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 400 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 600 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 800 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 1000 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 1200 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 1500 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 2000 mg | Oral |
| Subject | CILUPREVIR | Small molecule | 2400 mg | Oral |
Indications
No indication recorded.