Tolerability Clinical Trial
Official title:
A Phase I Study of Orally-administered AZD5213 in Healthy Males and Non-fertile Females Including Randomized, Double-blind, Placebo-controlled, Parallel-group Assessment of the Safety, Tolerability & PK of Single Ascending Dose (Part 1) & an Open-label Assessment of Effect of Food on the PK (Part 2)
1. The main purpose of this study is to assess the safety and tolerability of AZD5213
after single oral doses.
2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how
the study drug enters and leaves your body and how your body acts on the study drug) of
AZD5213 in your blood and urine.
One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of
AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and
then return to the clinic to receive AZD5213 after eating a high fat breakfast.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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