Phase1 Study of GR121167, Single and Multiple Dose Study in Healthy Japanese Males
Status:
Completed
Trial end date:
2011-04-04
Target enrollment:
Participant gender:
Summary
This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete
crossover, single and multiple dose study in healthy Japanese male subjects to assess the
pharmacokinetics and safety/tolerability of single and multiple intravenous administration of
GR121167. Serial blood samples and pooled urine samples for the determination of GR121167
concentration will be collected and safety assessments will be performed for each treatment
period.
The pharmacokinetics and dose proportionality of GR121167 after single intravenous
administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed.
In addition, in the final treatment period (600 mg), twice daily intravenous administrations
for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.