A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817985
• Other study ID #: GS-US-281-0112
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2013
• Last updated: August 28, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Diseases

Intervention

Drug:
• GS-5816

Locations

Country	Name	City	State
Puerto Rico	Investigational Site	San Juan
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of GS-5816	The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.	Up to one year	No
Secondary	Incidences of adverse events and laboratory abnormalities	The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.	Up to one year	Yes