Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers (ING)
|ClinicalTrials.gov Identifier: NCT01068925|
Recruitment Status : Completed
First Posted : February 15, 2010
Last Update Posted : January 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: GSK1349572||Phase 1|
The construction of a new antiretroviral regimen with GSK1349572 in raltegravir-resistant subjects will likely require less commonly used agents such as tipranavir and enfuvirtide. Ritonavir-boosted tipranavir (TPV/RTV) has been shown to induce drug metabolizing enzymes and lead to decreased exposure of some antiretrovirals thus necessitating a drug interaction study with GSK1349572 as GSK1349572 is eliminated primarily by metabolism.
This is a single-center, single sequence, open-label, three-period study, in adult male and female healthy subjects. Approximately 18 subjects will receive GSK1349572 50mg QD for 5 days (Treatment A). Subjects will then be administered TPV/RTV 500/200mg BID for 7 days (Treatment B) followed by the combination of GSK1349572 50mg QD and TPV/RTV 500/200mg for 5 days (Treatment C). There will be no washout periods between treatments. Safety evaluations will be collected during each treatment period. Serial PK samples for GSK1349572 will be collected and compared between Treatment A and C. A follow-up visit will occur 7-14 days after the last dose of study drug.
The study will be conducted at one centre in the US with healthy adult male and female subjects.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Open-Label, Single Sequence, Three-Period Drug Interaction Study of GSK1349572 and Tipranavir/Ritonavir in Healthy Adult Subjects (ING113096)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: ARM 1
GSK1349572 QD for 5 days (Treatment A).
Experimental: ARM 2
ARM 2: TPV/RTV 500/200mg BID (Treatment B).
Experimental: ARM 3
ARM 3: GSK1349572 50mg QD and TPV/RTV 500/200mg BID (Treatment C).
- Plasma GSK1349572 steady-state AUC(0-tau), Cmax, C0, Ctau, and Cmin following administration of GSK1349572 50mg QD for 5 days and following co-administration with TPV/RTV 500/200mg BID for 5 days. [ Time Frame: 17 days ]
- Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments. [ Time Frame: 31 days ]
- Plasma GSK1349572 PK parameters: tmax, tmin, CL/F and t½, following administration of GSK1349572 50mg QD for 5 days and following co-administration with TPV/RTV 500/200mg BID for 5 days [ Time Frame: 17 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068925
|United States, Texas|
|GSK Investigational Site|
|Austin, Texas, United States, 78744|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|