Study of VX-985 in Subjects With Chronic Hepatitis C

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT01144936

Run by

Vertex Pharmaceuticals Incorporated

People needed

21

Starts

2010-06-01

Expected to finish

2010-10-01

Last updated by the study team

2011-03-09

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kansas — Overland Park, Kansas, United States
• Maryland — Baltimore, Maryland, United States
• Washington — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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