Study of VX-985 in Subjects With Chronic Hepatitis C

NCT ID: NCT01144936

Last Updated: 2011-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-10-31

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Panel 1: VX-985 Dose 1

Group Type: EXPERIMENTAL

VX-985 or matching placebo

Intervention Type: DRUG

low dose

Panel 2: VX-985 Dose 2

Group Type: EXPERIMENTAL

VX-985 or matching placebo

Intervention Type: DRUG

high dose

Panel 3: VX-985 Dose 3

Group Type: EXPERIMENTAL

VX-985 or matching placebo

Intervention Type: DRUG

dose TBD

Interventions

VX-985 or matching placebo

low dose

Intervention Type: DRUG

VX-985 or matching placebo

high dose

Intervention Type: DRUG

VX-985 or matching placebo

dose TBD

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Vertex Pharmaceuticals Incorporated

Principal Investigators

Lisa Mahnke, MD, PhD

Role: STUDY_DIRECTOR

Vertex Pharmaceuticals Incorporated

Locations

Kansas

Overland Park, Kansas, United States

Maryland

Baltimore, Maryland, United States

Washington

Tacoma, Washington, United States

Countries

United States

Other Identifiers

VX09-985-101

Identifier Type: -

Identifier Source: org_study_id