Pharmacokinetics of GS-9857 in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:March 2015
End Date:March 2016

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A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single
dose of GS-9857 in adults with normal and impaired hepatic function. Adults in the healthy
control group will be matched to adults with impaired hepatic function by gender, age (± 10
years), and body mass index (± 15%).


Inclusion Criteria:

- All individuals:

- Screening laboratory values within defined thresholds for group

- Use of two effective contraception methods if female of childbearing potential
or sexually active male

- For individuals with moderate hepatic impairment:

- Diagnosis of chronic (> 6 months) hepatic impairment

- Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh
Class B).

- For individuals with severe hepatic impairment:

- Diagnosis of chronic (> 6 months) hepatic impairment

- Score on the CPT scale of 10-15 at screening (Child Pugh Class C)

- For individuals with normal hepatic function:

- Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

Exclusion Criteria:

- All individuals:

- Pregnant or nursing female or male with pregnant female partner

- HIV infection

- History of clinically significant illness or any other medical disorder that may
interfere with the individual's treatment, assessment or compliance with the
protocol

- For individuals with moderate or severe hepatic impairment:

- Active HCV infection

- Current hepatic encephalopathy

- Variceal bleeding in the last 6 months unless banded

- Prior placement of a portosystemic shunt

- History of hepatorenal or hepatopulmonary syndrome

- Spontaneous bacterial peritonitis currently or within the last 6 months

- Hospitalization within the last 2 months related to cirrhosis

- Confirmed hypotension

- Suspicion of hepatocellular carcinoma
We found this trial at
3
sites
San Antonio, Texas 78215
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San Antonio, TX
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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München, 81241
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München,
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