The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
64
Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1. Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal
In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1
Research Site
Overland Park, Kansas, United States
Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
Time frame: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.
To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.
Time frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose.
To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847
Time frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose
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