Healthy Subjects Clinical Trial
Official title:
A Double Blind, Randomized and Placebo Controlled Ascending Single Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ASP1707 in Healthy Young Japanese Male Subjects
Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and distributed through the body.
The first group receives the lowest dose while the last group receives the highest dose.
ASP1707 or matching placebo is administered as a single dose under fasted conditions.
Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1
and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge.
Escalation to the next higher dose takes place after review of the safety and tolerability
data from the previous dose.
Safety assessments are performed throughout the study. Plasma and urine samples are
collected for pharmacokinetics (PK) analysis. Serum samples are collected for
pharmacodynamic (PD) analysis.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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