Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

• Status: Completed
• Trial end date: 2011-12-05
• Target enrollment: 0
• Participant gender: All

Summary

GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with chronic hepatitis C (CHC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: PPD
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Key Inclusion Criteria:

• Documented chronic genotype 1 or genotype 4 HCV infection

• Naïve to all HCV antiviral treatment(s)

• Agree to IL28B genotyping

• A body mass index >18 kg/m2 but not exceeding 36 kg/m2

• Liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic. If no recent (<36 months) liver biopsy is available, a study qualifying biopsy must be performed prior to Baseline (Day 1)

• All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment ends

• Otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening

Key Exclusion Criteria:

• Positive test at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody

• History of any other clinically significant chronic liver disease

• History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease

• Positive results on urine screen for drugs of abuse test at Screening (unless used as medical treatment, e.g., with a prescription)

• History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation program)

• Screening ECG corrected QT interval value greater than 450 ms and/or clinically significant ECG findings

• A personal or family history of Torsade de Pointes findings

• Pregnant or nursing women

• Males with a female partner who is pregnant

• Abnormal hematological and biochemical parameters as specified in the protocol

• History of major organ transplantation with an existing functional graft

• Thyroid dysfunction not adequately controlled

• Subjects with a history of suicide attempt or hospitalization for depression in the past 5 years and/or any current (within 6 months) severe or poorly controlled psychiatric disorder

• History or current evidence of immunologic disorder; pulmonary, cardiac, or pulmonary disease; seizure disorder; cancer or history of malignancy that in the opinion of the investigator makes the subject unsuitable for the study

• Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to first dose administration