drugset
drugset / Trial / NCT01121302

Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

NCT01121302 ↗

Phase 1 Completed 88 enrolled AstraZeneca
RandomizedSingle-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2010-05
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD5213 Unknown 0.1 mg Oral
Subject AZD5213 Unknown 0.3 mg Oral
Subject AZD5213 Unknown 1 mg Oral
Subject AZD5213 Unknown 2 mg Oral
Subject AZD5213 Unknown 4 mg Oral
Subject AZD5213 Unknown 8 mg Oral
Subject AZD5213 Unknown 16 mg Oral
Subject AZD5213 Unknown 32 mg Oral

Indications

No indication recorded.