AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

Key facts

Study ID

NCT00912353

Run by

AstraZeneca

People needed

56

Starts

2009-05-01

Expected to finish

2009-10-01

Last updated by the study team

2013-01-29

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
• Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)
• 18 to ≤ 27 kg/m2

You may not qualify if…

• Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
• Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
• Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Where it is running

• Research Site — Gelndale, California, United States

Full record on ClinicalTrials.gov

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