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OpenTrials
Completed

NCT Number: NCT01497327

Open-Label Hepatic Impairment Study

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSI-352938

Drug

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

PSI-7977

Drug

PSI-7977 400mg QD for seven days

Primary outcomes

  1. Pharmacokinetic data derived from plasma samples collected over 7 days

    Time frame: 28 time points over Seven Days

    To characterize the pharmacokinetics (PK) of PSI-352938 over 7 days of dosing with PSI-352938 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.

  2. Pharmacokinetic comparison with historical data over 7 days of dosing with PSI-7977

    Time frame: Seven Days

    To characterize the PK of PSI-7977 and metabolites over 7 days of dosing with PSI-7977 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.

Secondary outcomes

  1. Number and severity of adverse events

    Time frame: Seven Days

    To assess the safety and tolerability of 7 days of dosing of PSI-352938 or PSI-7977 in HCV infected patients with varying degrees of hepatic impairment.

  2. Viral dynamics/ changes in HCV (ribonucleic acid) RNA

    Time frame: Baseline through follow-up (post-Day 14)

    To evaluate the viral dynamics as measured by changes in the HCV RNA in HCV-infected patients with varying degrees of hepatic impairment after 7 days of dosing with PSI-352938 or PSI-7977.

  3. Changes in genotypic or phenotypic measurements

    Time frame: Seven Days

    To assess the presence of baseline polymorphisms in viral isolates and development of viral genotypic and phenotypic changes from baseline.

  4. Dosage adjustment in hepatically impaired patients

    Time frame: Seven days

    To provide dosage adjustment guidance for PSI-352938 or PSI-7977 based on the degree of hepatic impairment, if applicable.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

An Open-Label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of PSI-7977 or PSI-352938 in HCV-infected Subjects With Varying Degrees of Hepatic Impairment

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2011
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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