Study of VX-985 in Subjects With Chronic Hepatitis C

NCT01144936 | Completed Phase 1

• 1 other identifier: VX09-985-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

  10-13 days

Secondary Outcomes (2)

• Plasma pharmacokinetic parameters of VX-985

  10-13 days

• HCV RNA levels

  5-7 months

Study Arms (3)

Panel 1: VX-985 Dose 1

EXPERIMENTAL

Drug: VX-985 or matching placebo

Panel 2: VX-985 Dose 2

EXPERIMENTAL

Drug: VX-985 or matching placebo

Panel 3: VX-985 Dose 3

EXPERIMENTAL

Drug: VX-985 or matching placebo

Interventions

VX-985 or matching placebo DRUG

low dose

Panel 1: VX-985 Dose 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (3)

Kansas

Overland Park, Kansas, United States

Location

Maryland

Baltimore, Maryland, United States

Location

Washington

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Mahnke, MD, PhD

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 9, 2011

Record last verified: 2011-03

Locations

US (3)