AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.

Key facts

Study ID

NCT00935025

Run by

AstraZeneca

People needed

45

Starts

2009-07-01

Expected to finish

2009-11-01

Last updated by the study team

2010-12-07

Who can join

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

You may qualify if…

• Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
• Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2

You may not qualify if…

• Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
• History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
• Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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