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

A Single-center, Single-blind, Randomized, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Oral Doses of AZD1305 Extended-release Capsules in Healthy Male Japanese and Caucasian Subjects

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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