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Completed

NCT Number: NCT01817985

A Phase 1 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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

GS-5816

Drug

Primary outcomes

  1. Pharmacokinetic parameters of GS-5816

    Time frame: Up to one year

    The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.

Secondary outcomes

  1. Incidences of adverse events and laboratory abnormalities

    Time frame: Up to one year

    The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2013
Registry last updated
Aug 29, 2013

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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