This study will be the first repeat dose administration of GSK1322322 to investigate safety, tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects. The study will also include a P450 probe drug (midazolam) to evaluate the effect of GSK1322322 to inhibit or induce CYP3A4 substrates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
GSK1322322/placebo escalating doses from 500mg to 1500mg
GSK1322322/placebo and 5mg midazolam
GSK Investigational Site
Randwick, New South Wales, Australia
GSK1322322 safety parameters, adverse events , absolute values and changes over time of clinical lab testing, vital signs, electrocardiogram
Time frame: 6 weeks
GSK1322322 pharmacokinetic parameters following single dose administration on Day 1 and following repeat administration where applicable on Day 7 and Day 12.
Time frame: 15 days
PK for midazolam with and without GSK1322322
Time frame: 15 days
Blood PK for GSK1322322
Time frame: 15 days
Urine PK for GSK1322322
Time frame: 15 days
GSK1322322 Age Effect on PK Blood and Urine
Time frame: 15 days
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