Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects

ClinicalTrials.gov ID: NCT01827657

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Official title

A Phase I, Open-Label, Parallel-Group, Two-Part Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects (HAI117380)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a single-dose, open-label, two part, parallel group study. This study is being conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects with mild and moderate hepatic impairment and healthy control subjects matched to the subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be based on a review of the preliminary safety and pharmacokinetic data from subjects with moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment. Additionally, based on emergent data from Part 1, matched controls to the severe hepatic group may be enrolled (optional). Due to the potential difficulty in identifying eligible subjects with severe hepatic impairment, the study may be stopped prior to full enrollment in Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic impairment have been enrolled. The study will consist of a Screening visit, a single dose Treatment Period and a Follow-up visit. Subjects will be screened for eligibility criteria within 30 days of enrolment. Subjects will be admitted to the clinical unit on Day -1; each subject will receive a single dose of GSK2336805 on Day 1 and will remain in the clinical unit for 5 days (check-out on Day 4). The follow-up visit will be conducted within 7-10 days after Day 1 dosing.

Study identification

NCT ID: NCT01827657
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: GlaxoSmithKline; Industry
Enrollment: 31 participants

Conditions and interventions

Conditions

Hepatitis C

Interventions

GSK2336805 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 74 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 28, 2013 (Actual)
Primary completion: Mar 20, 2014 (Actual)
Completion: Mar 20, 2014 (Actual)
Last update posted: Jun 14, 2017

2013 – 2014

United States locations

U.S. sites: 4
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
GSK Investigational Site	Lakewood	Colorado	80228	—
GSK Investigational Site	Orlando	Florida	32809	—
GSK Investigational Site	Minneapolis	Minnesota	55404	—
GSK Investigational Site	Knoxville	Tennessee	37920	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01827657, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 14, 2017 · Synced Nov 12, 2026