Ignite Creation Date:
2024-05-05 @ 11:01 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01231529
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2010-10-14
Brief Title:
GSK1349572 Hepatic Impairment Study
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase I Open-Label Parallel-Group Two-Part Adaptive Study to Evaluate the Pharmacokinetics and Safety of GSK1349572 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects ING113097
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GSK1349572 is an integrase inhibitor that is currently in clinical development for the treatment of human immunodeficiency virus HIV infection GSK1349572 is metabolized primarily by uridine diphosphate glucuronosyltransferase UGT1A1 with a minor role of Cytochrome P450 CYP3A Hepatic impairment could potentially alter the clearance and plasma protein binding of GSK1349572 This study will evaluate the single dose pharmacokinetics and safety of GSK1349572 in healthy subjects and in subjects with mild or moderate hepatic impairment based on Child-Pugh category
This is a single-dose open-label parallel group two-part adaptive study in adult males and females with mild or moderate hepatic impairment and matched healthy control subjects with normal hepatic function Healthy control subjects 16 will be matched for gender age and BMI to the subjects in the mild 8 or moderate 8 hepatic impairment category In Part 1 approximately 8 subjects with moderate hepatic impairment cohort 1 and 8 matched control subjects cohort 2 will each receive GSK1349572 50 mg as a single dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in plasma Free unbound plasma concentrations of GSK1349572 will also be evaluated at sparse selected time points If the geometric mean total plasma area under the concentration curve AUC of GSK1349572 is increased by 2-fold in moderately impaired subjects compared to matched controls Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in another group of subjects with mild impairment 8 cohort 3 and matched control subjects 8 cohort 4 Vital signs electrocardiograms ECGs and adverse events will be monitored throughout the study A follow-up visit will occur 7-10 days after the dose of study drug
This is a single-dose open-label parallel group two-part adaptive study in adult males and females with mild or moderate hepatic impairment and matched healthy control subjects with normal hepatic function Healthy control subjects 16 will be matched for gender age and BMI to the subjects in the mild 8 or moderate 8 hepatic impairment category In Part 1 approximately 8 subjects with moderate hepatic impairment cohort 1 and 8 matched control subjects cohort 2 will each receive GSK1349572 50 mg as a single dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in plasma Free unbound plasma concentrations of GSK1349572 will also be evaluated at sparse selected time points If the geometric mean total plasma area under the concentration curve AUC of GSK1349572 is increased by 2-fold in moderately impaired subjects compared to matched controls Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in another group of subjects with mild impairment 8 cohort 3 and matched control subjects 8 cohort 4 Vital signs electrocardiograms ECGs and adverse events will be monitored throughout the study A follow-up visit will occur 7-10 days after the dose of study drug
Detailed Description:
ViiV Healthcare is the new sponsor of this study and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None