Herpes Zoster Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151
The objective of this study is to evaluate the safety and tolerability of single rising
doses of ASP2151 under fasted condition in healthy male subjects.
The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under
fasted versus fed conditions in healthy male subjects.
Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of
ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum
tolerable dose (MTD) if possible.
Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability
and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the
two treatment cycles will be at least 5 days and not shorter than five times the average
elimination half-life of ASP2151, as determined in part 1 of the study.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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