A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/30/-0001 |
| Start Date: | March 2013 |
| End Date: | October 2013 |
| Contact: | Karim Sajwani, MPH |
| Email: | Karim.Sajwani@gilead.com |
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the
Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe
hepatic impairment.
Inclusion Criteria:
- Diagnosis of chronic (> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
Exclusion Criteria:
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
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