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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
45
Research Site
Glendale, California, United States
Research Site
Baltimore, Maryland, United States
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
Time frame: During the study, from screening period to follow-up, 50 days approximately
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses
Time frame: From predose until 48 hrs post last dose
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