This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.
This study will consist of six treatment periods. A total of 16 healthy male and female participants of non-childbearing potential will be randomized in this study to ensure at least 12 evaluable participants at the end of the last treatment period. The study will comprise of a Screening Period, six Treatment Periods, and a follow-up phone call: * A screening period of maximum 28 days. * Six treatment periods during which participants will be residents at the study center from Day -1 until Day 17. Each participant will receive 6 treatments. The following treatments will be given:- * Treatment A: Dose A of AZD5462 film-coated tablet in a fasted state. * Treatment B: Dose A of AZD5462 film-coated tablet in a fed state. * Treatment C: Dose B of AZD5462 film-coated tablet in a fasted state. * Treatment D: Dose B of AZD5462 oral solution in a fasted state. * Treatment E: Dose C of AZD5462 film-coated tablet in a fasted state. * Treatment F: Dose C of AZD5462 film-coated tablet in a fed state. * A follow-up phone call will take place on Day 21 (± 1 day) to record adverse events (AEs) and concomitant medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will receive AZD5462 orally.
Research Site
Brooklyn, Maryland, United States
Area under plasma concentration time curve from zero to infinity (AUCinf)
The AUCinf of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Time frame: Day 1 to Day 17
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
The AUClast of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Time frame: Day 1 to Day 17
Maximum observed plasma (peak) drug concentration [Cmax]
The Cmax of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Time frame: Day 1 to Day 17
Area under plasma concentration time curve from zero to infinity (AUCinf)
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUCinf of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Time frame: Day 1 to Day 17
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUClast of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Time frame: Day 1 to Day 17
Maximum observed plasma (peak) drug concentration [Cmax]
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the Cmax of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Time frame: Day 1 to Day 17
Area under plasma concentration time curve from zero to infinity (AUCinf)
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUCinf.
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Time frame: Day 1 to Day 17
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUClast.
Time frame: Day 1 to Day 17
Maximum observed plasma (peak) drug concentration [Cmax]
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of Cmax.
Time frame: Day 1 to Day 17
Number of participants with Adverse Events (AEs), and Serious Adverse Events (SAEs)
The safety, and tolerability of single doses of AZD5462 in healthy participants will be assessed.
Time frame: Until follow-up (Day 21)