Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

All subjects

• Subjects are in good general health.

• Subjects have provided written informed consent form.

• All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects

• Documented clinical history compatible with chronic hepatitis C without cirrhosis.

• Treatment-naïve

• HCV Genotype 1

Exclusion Criteria:

All subjects

• Pregnant or breastfeeding

• Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

• Decompensated liver disease

• Other clinically significant medical conditions or laboratory abnormalities.