Study of VX-985 in Subjects With Chronic Hepatitis C

Vertex Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Chronic Hepatitis C

Treatments

Drug: VX-985 or matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01144936

VX09-985-101

Details and patient eligibility

About

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.

Enrollment

21 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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