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Completed

NCT Number: NCT01144936

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kansas, Overland Park, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-985 or matching placebo

Drug

low dose

Primary outcomes

  1. Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events)

    Time frame: 10-13 days

Secondary outcomes

  1. Plasma pharmacokinetic parameters of VX-985

    Time frame: 10-13 days

  2. HCV RNA levels

    Time frame: 5-7 months

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of VX-985 in Subjects With Genotype 1 Chronic Hepatitis C

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2010
Registry last updated
Mar 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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