Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15.
Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.
Age
19–65
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m
Must agree to use an acceptable double-barrier method of birth control.
Must provide written informed consent after the study has been fully explained.
You may not be if
History of clinically significant diseases, as determined by the investigator.
Safety laboratory abnormalities at screening which are clinically significant.
Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
