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Study of VX-985 in Subjects With Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144936
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : March 9, 2011
Information provided by:
Vertex Pharmaceuticals Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: VX-985 or matching placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of VX-985 in Subjects With Genotype 1 Chronic Hepatitis C
Study Start Date : June 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Panel 1: VX-985 Dose 1 Drug: VX-985 or matching placebo
low dose

Experimental: Panel 2: VX-985 Dose 2 Drug: VX-985 or matching placebo
high dose

Experimental: Panel 3: VX-985 Dose 3 Drug: VX-985 or matching placebo
dose TBD

Primary Outcome Measures :
  1. Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events) [ Time Frame: 10-13 days ]

Secondary Outcome Measures :
  1. Plasma pharmacokinetic parameters of VX-985 [ Time Frame: 10-13 days ]
  2. HCV RNA levels [ Time Frame: 5-7 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144936

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United States, Kansas
Overland Park, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Washington
Tacoma, Washington, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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Study Director: Lisa Mahnke, MD, PhD Vertex Pharmaceuticals Incorporated
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Responsible Party: Lisa Mahnke, Vertex Pharmaceuticals Incorporated Identifier: NCT01144936    
Other Study ID Numbers: VX09-985-101
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections