Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01098526
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2010-03-04
Brief Title:
GSK1349572 Drug Interaction Study With Efavirenz
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase 1 Open Label Single Sequence Three Period Study to Evaluate the Single Dose Pharmacokinetics of GSK1349572 100mg Versus 50mg and the Effect of Efavirenz 600mg Once Daily on the Pharmacokinetics Safety and Tolerability of GSK1349572 50mg Once Daily in Healthy Adult Subjects ING114005
Status:
COMPLETED
Status Verified Date:
2017-09
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 Phase 2 clinical trials for the treatment of HIV infection As GSK1349572 development progresses it may be dosed with non-nucleoside HIV reverse transcriptase inhibitors NNRTIs including efavirenz EFV Sustiva Efavirenz is a known inducer of CYP3A4 GSK1349572 is primarily metabolized via UGT1A1 however it also has a CYP component to its metabolism thus a drug interaction between GSK1349572 and EFV is likely A previous study showed that another NNRTI etravirine which is also a known inducer of CYP3A and UGT reduced GSK1349572 exposure significantly GSK1349572 is not an inhibitor or inducer of CYP3A and is not expected to have impact on pharmacokinetics PK of EFV
This study will investigate the dose proportionality between single doses of 50mg and 100mg of GSK1349572 and will compare steady-state plasma PK safety and tolerability of GSK1349572 50 mg every 24h q24h with and without efavirenz 600 mg q24h Approximately 12 subjects will receive a single dose of GSK1349572 100 mg Treatment A in Period 1 followed by a washout of greater than or equal to 6 days In Period 2 subjects will receive GSK1349572 50mg q24h for 5 days Treatment B Subjects will then be administered GSK1349572 50mg q24h in the morning in combination with EFV 600 mg q24h Treatment C in the evening for 14 days in Period 3 There will be no washout between Periods 2 and 3 Safety evaluations and serial PK samples for GSK1349572 will be collected during each treatment period A follow-up visit will occur 7-14 days after the last dose of study drug
This study will be conducted at one center in the US with healthy adult male and female subjects
This study will investigate the dose proportionality between single doses of 50mg and 100mg of GSK1349572 and will compare steady-state plasma PK safety and tolerability of GSK1349572 50 mg every 24h q24h with and without efavirenz 600 mg q24h Approximately 12 subjects will receive a single dose of GSK1349572 100 mg Treatment A in Period 1 followed by a washout of greater than or equal to 6 days In Period 2 subjects will receive GSK1349572 50mg q24h for 5 days Treatment B Subjects will then be administered GSK1349572 50mg q24h in the morning in combination with EFV 600 mg q24h Treatment C in the evening for 14 days in Period 3 There will be no washout between Periods 2 and 3 Safety evaluations and serial PK samples for GSK1349572 will be collected during each treatment period A follow-up visit will occur 7-14 days after the last dose of study drug
This study will be conducted at one center in the US with healthy adult male and female subjects
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