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Study of VX-985 in Subjects With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01144936
First received: June 14, 2010
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Chronic Hepatitis C
 Drug: VX-985 or matching placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events) [ Time Frame: 10-13 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma pharmacokinetic parameters of VX-985 [ Time Frame: 10-13 days ] [ Designated as safety issue: No ]
  • HCV RNA levels [ Time Frame: 5-7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144936

Locations
United States, Kansas
Kansas
Overland Park, Kansas, United States
United States, Maryland
Maryland
Baltimore, Maryland, United States
United States, Washington
Washington
Tacoma, Washington, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Lisa Mahnke, MD, PhD Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Lisa Mahnke, Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01144936     History of Changes
Other Study ID Numbers: VX09-985-101
Study First Received: June 14, 2010
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013