Clinical trial NCT01144936: Study of VX-985 in Subjects With Chronic Hepatitis C
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events)
timeFrame: 10-13 days
Secondary outcomes:
measure: Plasma pharmacokinetic parameters of VX-985
timeFrame: 10-13 days
measure: HCV RNA levels
timeFrame: 5-7 months
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas
state: Kansas
city: Baltimore
country: United States
facility: Maryland
state: Maryland
city: Tacoma
country: United States
facility: Washington
state: Washington
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Lisa Mahnke, MD, PhD
role: STUDY_DIRECTOR
References: