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 |
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%).
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
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878

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