The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
128
Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast)
Multiple oral doses of AZD4316 suspension. It's planned that doses will be administered in the fasted state, however, if in Part A it's shown that food increases absorption of AZD4316, then doses will be administered after a meal.
Placebo to match AZD4316
Research Site
London, United Kingdom
Number of participants with adverse events
Time frame: from screening period to follow-up
Assesment of vital signs (blood pressure, pulse and temperature)
Frequent assessments will be made for each subject from the screening period to follow up
Time frame: from screening period to follow-up
Assessment of laboratory variables and physical examinations
Frequent assessments will be made for each subject from the screening period to follow up
Time frame: from screening period to follow-up
Assessment of Electrocardiogram (ECG) variables
Frequent assessments will be made for each subject from the screening period to follow up
Time frame: from screening period to follow-up
Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine
Time frame: Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit
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