Open-Label Hepatic Impairment Study

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.

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Detailed Description

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This study is designed per the Food and Drug Administration (FDA) guidance for patients with impaired hepatic function to assess the influence of hepatic impairment on the PK and pharmacodynamics (PD) of PSI-7977 and PSI-352938 This study will be conducted in Hepatitis C positive patients to ascertain whether the PD effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies. Data from subjects who participated in the P2938-0212 study (PSI-352938 MAD) will be used as the control group. These subjects were documented non-cirrhotic subjects with normal hepatic function. Hepatitis C Virus (HCV) Genotypes 1-6 will be enrolled in this study.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PSI-352938 Group A

Mild (Child-Pugh Class A; 5-6) hepatic impairment

Group Type EXPERIMENTAL

PSI-352938

Intervention Type DRUG

PSI-352938 300mg once daily (QD) for seven days

PSI-352938 Group B

Moderate (Child-Pugh Class B; 7-9) hepatic impairment

Group Type EXPERIMENTAL

PSI-352938

Intervention Type DRUG

PSI-352938 300mg once daily (QD) for seven days

PSI-352938 Group C

Severe (Child-Pugh Class C; 10-15) hepatic impairment

Group Type EXPERIMENTAL

PSI-352938

Intervention Type DRUG

PSI-352938 300mg once daily (QD) for seven days

PSI-7977 Group A

Mild (Child-Pugh Class A; 5-6) hepatic impairment

Group Type EXPERIMENTAL

PSI-7977

Intervention Type DRUG

PSI-7977 400mg QD for seven days

PSI-7977 Group B

Moderate (Child-Pugh Class B; 7-9) hepatic impairment

Group Type EXPERIMENTAL

PSI-7977

Intervention Type DRUG

PSI-7977 400mg QD for seven days

PSI-7977 Group C

Severe (Child-Pugh Class C; 10-15) hepatic impairment

Group Type EXPERIMENTAL

PSI-7977

Intervention Type DRUG

PSI-7977 400mg QD for seven days

Interventions

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PSI-352938

PSI-352938 300mg once daily (QD) for seven days

Intervention Type DRUG

PSI-7977

PSI-7977 400mg QD for seven days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hepatic impaired Males or females of non-childbearing potential aged \> 18 years with Chronic HCV-infection
* Naïve to all direct acting anti-viral (DAA) treatments for chronic HCV infection.
* Documented Cirrhosis

Exclusion Criteria

* Prior PEG/RBV null responders.
* Unstable cardiac disease, recent Myocardial infarction, or family history of QTc prolongation or unexplained cardiac arrest.
* Positive test at Screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-human immunodeficiency virus (HIV) Ab.
* History of clinically significant medical condition associated with other chronic liver disease
* Any current signs or symptoms of severe hepatic encephalopathy
* History of gastric or esophageal variceal bleeding in which varices have not been adequately treated with medication and surgical procedures
* Prior placement of a portosystemic shunt
* History of hepatorenal, or hepatopulmonary syndrome.
* Active spontaneous bacterial peritonitis.
* Use of medications associated with QT prolongation within 28 days prior to dosing.
* Current Hypotension
* History of Torsades de Pointes, evidence of an active or suspected cancer, or a history of malignancy, Abnormal hematological and biochemical parameters

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No