Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-01-31

Brief Summary

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This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels.

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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet given once or three times daily for 15 consecutive days

SCY-635 30 mg once daily

Group Type ACTIVE_COMPARATOR

SCY-635

Intervention Type DRUG

oral capsule

SCY-635 100 mg once daily

Group Type ACTIVE_COMPARATOR

SCY-635

Intervention Type DRUG

oral capsule

SCY-635 300 mg once daily

Group Type ACTIVE_COMPARATOR

SCY-635

Intervention Type DRUG

oral capsule

SCY-635 100 mg three times daily

Group Type ACTIVE_COMPARATOR

SCY-635

Intervention Type DRUG

oral capsule

SCY-635 200 mg three times daily

Group Type ACTIVE_COMPARATOR

SCY-635

Intervention Type DRUG

oral capsule

SCY-635 300 mg three times daily

Group Type ACTIVE_COMPARATOR

SCY-635

Intervention Type DRUG

oral capsule

Interventions

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Placebo

Oral tablet given once or three times daily for 15 consecutive days

Intervention Type DRUG

SCY-635

oral capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject is either male or female, between the ages of 18 and 65 years (inclusive).
* The subject has read and signed a Subject Informed Consent form to participate in the study. If the subject is not fluent in English, the Subject Informed Consent form must be translated into his or her native language.
* Female subjects of childbearing potential (i.e., women not surgically sterile or at least two years postmenopausal) must agree to utilize one of the following forms of contraception from Screening through completion of the study: abstinence, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum). Hormonal contraception (oral, transdermal, implant, or injection) is not permitted during the study period (i.e., from Screening through the Follow-up visit). Note: For women aged \<50 years, postmenopausal is defined as at least two years cessation of menses. For women aged ≥50 years, postmenopausal is defined as at least one year cessation of menses. Estrogen replacement is allowed during the study.
* The subject exhibits quantifiable plasma levels of HCV-specific RNA in excess of 100,000 IU/mL as determined by the quantitative Roche COBAS taqMan assay.
* The subject has a negative urine screen for amphetamines, barbiturates, cocaine, opiates, and phencyclidine at Screening.
* If female, the subject has a negative serum pregnancy test at Screening (within 30 days prior to dosing) and a negative urine pregnancy test on Study Day -1.

Exclusion Criteria

* The subject has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Principal Investigator, may jeopardize the safety of the subject or may impact the validity of the study results.
* The subject is infected with any HCV genotype other than genotype 1.
* The subject has documented positive antibody tests for Human Immunodeficiency Virus Types 1 or 2 (p24 antibody specific for HIV-1 or HIV-2) or Hepatitis B virus (HBV) surface antigen (HbSAg) or at Screening exhibits serologic evidence of infection with either HIV-1, HIV-2 or HBV.
* The subject has donated blood within 30 days prior to dosing or donated plasma within 14 days prior to dosing.
* The subject has used any investigational agent within three months prior to dosing.
* The subject has received any FDA-approved anti-HCV therapy (including ribavirin or any product that contains interferon) within three months prior to dosing.
* The subject exhibits evidence of decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2 seconds prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
* The subject is an organ transplant recipient.
* The subject exhibits ALT values greater than or equal to 2.5 times the upper limit of normal.
* The subject exhibits evidence of hepatocellular carcinoma either by exhibiting a serum alpha-fetoprotein concentration which exceeds 50 mg/L or by exhibiting a mass suggestive of liver cancer by ultrasound or other imaging technology.
* The subject exhibits evidence of ongoing alcohol or substance abuse.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No