GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of HIV infection. The primary objective of this study is to determine whether the addition of a proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition, the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of GSK1349572 will be evaluated.
Official Study Title: A randomized, double-blind study to evaluate the safety, tolerability, and pharmacokinetics of a supratherapeutic dose of GSK1349572 250 mg and a randomized, open-label study to evaluate the effects of omeprazole 40 mg daily and a high fat meal on the pharmacokinetics of GSK1349572 50 mg in healthy adult subjects (ING112941)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
GSK1349572 250 mg suspension as a single dose. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.
GSK1349572 50 mg tablets as a single dose on three separate occasions. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.
Placebo Suspension as a single dose.
GSK Investigational Site
Baltimore, Maryland, United States
Plasma GSK1349572 PK parameters following a single-dose administration of 50 mg under fasted conditions with and without omeprazole 40 mg
Time frame: 16 days
Plasma GSK1349572 PK parameters following a single-dose administration of 50 mg under fasted conditions and with a high-fat meal
Time frame: 9 days
Plasma GSK1349572 PK parameters following a single-dose administration of 250 mg under fasted conditions
Time frame: 3 days
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments following a single supratherapeutic dose of GSK1349572 250 mg.
Time frame: 3 days
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments following a single-dose administration of 50 mg under fasted conditions, with a high-fat meal, and with OMP 40 mg.
Time frame: 16 days
Plasma GSK1349572 PK parameters following a single-dose administration of 50 mg under fasted conditions, with a high-fat meal, and with OMP 40 mg
Time frame: 16 days
Plasma GSK1349572 PK parameters following a single-dose administration of 250 mg under fasted conditions
Time frame: 3 days
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Omeprazole 40 mg once a day for 5 days. Omeprazole is approved by the FDA currently to reduce stomach acid, treat stomach ulcers, and gastroesophageal reflux disease.