drugset / Trial / NCT01974687
Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.
Timeline
- Start
- 2013-10-31
- Primary completion
- 2015-09-02
- Completion
- 2015-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Uprifosbuvir | Other / unclassified | 10 mg | Oral |
| Subject | Uprifosbuvir | Other / unclassified | 50 mg | Oral |
| Subject | Uprifosbuvir | Other / unclassified | 150 mg | Oral |
| Subject | Uprifosbuvir | Other / unclassified | 300 mg | Oral |
| Subject | Uprifosbuvir | Other / unclassified | 400 mg | Oral |
| Subject | Uprifosbuvir | Other / unclassified | 450 mg | Oral |
| Background | Itraconazole | Small molecule | 200 mg | Oral |