Study of VX-985 in Subjects With Chronic Hepatitis C
Study of VX-985 in Subjects With Chronic Hepatitis C
The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV
 subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of
 VX-985.
Inclusion Criteria:

 -  Subjects who are male or females of non-childbearing potential aged 18 to 64
 years(inclusive) with a body mass index (BMI) between 18 and 32 (kg/m2)

 -  Certain subjects must agree to use acceptable contraceptive methods as specified in
 protocol

 -  Subjects who are treatment naïve and are infected with genotype 1 chronic hepatitis C

 -  Subjects must be in good health and have normal laboratory values as judged by
 investigator

 -  Subjects must not have clinically significant abnormal results for physical
 examination

 Exclusion Criteria:

 -  Subjects must not have received approved or experimental HCV therapy

 -  Subjects must not have evidence of hepatic decompensation: history of ascites, hepatic
 encephalopathy, or bleeding esophageal varices

 -  Subjects must not have any known history of other cause of significant liver disease
 including hepatitis B, drug or alcohol-related cirrhosis, etc

 -  Subjects must not be diagnosed with or have suspected hepatocellular carcinoma

 -  Subjects must not have histologic evidence of hepatic cirrhosis on any liver biopsy or
 test capable of detecting cirrhosis within the past 2 years

 -  Subjects with a known history or other evidence of severe retinopathy or clinically
 significant ophthalmological disorder

 -  Subjects must not have a history of any illness that might confound the results of the
 study or pose an additional risk in administering study drug(s) to the subject e.g.
 history of cardiovascular or central nervous system disease, ongoing psychiatric
 disorder, poorly controlled diabetes, etc

 -  Subject must not have taken any of the prohibited medications within the specified
 time before study start or take certain medications (including herbal supplements)
 during the study

 -  Subjects must not have a history of drug or alcohol abuse or addiction within 6 months
 before the start of dosing, or test positive for alcohol or drugs of abuse

 -  Subjects must not have donated or had a significant loss of blood within 56 days of
 the start of dosing, or donated more than 1 unit of plasma within 7 days before the
 start of dosing

 -  Subjects must not consume excessive amounts of caffeine

 -  Subjects must not have participated in a clinical study involving administration of
 either an investigational or a marketed drug within 2 months

 -  Subjects who are female and have a positive pregnancy test and/or who are considered
 to be of childbearing potential or are nursing.

 -  Subjects that have a female partner who is pregnant, nursing, or planning to become
 pregnant during the study or shortly after the study