The main aim of this study to compare the pharmacokinetics (PK) of two formulations of AZD4144 and assess the effect of food and omeprazole on PK of AZD4144 in healthy participants.
This is an open-label, randomized, single-dose, crossover Phase I study. The study will comprise: 1. A Screening Period of 28 days. 2. Three Residential Periods 3. A final Follow-up period within 7 to 10 days after the last dose of study drug. There will be a minimum washout period of 7 days between each AZD4144 dose. This study includes the following 2 arms: Arm 1 consists of 3 treatments: 1. Treatment A: AZD4144 dose 1 as tablet (under fasted condition) 2. Treatment B: AZD4144 dose 1 as tablet (under fed condition) 3. Treatment C: AZD4144 dose 1 as an oral solution (under fasted condition) Arm 2 consists of 3 treatments: 1. Treatment D: AZD4144 dose 2 as tablet (under fasted condition) 2. Treatment E: AZD4144 dose 2 as tablet (under fed condition) 3. Treatment F: Omeprazole once daily for 4 days, followed by a single dose of omeprazole along with a single dose of AZD4144 dose 2 as tablet (under fasted condition). The participants will be randomised to one of the following treatment sequences: Arm 1: ABC, BCA or CAB Arm 2: DEF or EDF
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants will receive AZD4144 orally.
Participants will receive omeprazole orally.
Research Site
Harrow, United Kingdom
Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
Time frame: Days 1-4, Days 8-11 and Days 15-18
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD4144
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
Time frame: Days 1-4, Days 8-11 and Days 15-18
Maximum observed drug concentration (Cmax) of AZD4144
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
Time frame: Days 1-4, Days 8-11 and Days 15-18
Number of participants with adverse events (AEs)
To assess the safety and tolerability of single doses of AZD4144 in healthy participants.
Time frame: From Day 1 to Day 25
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Number of participants with serious AEs
To assess the safety and tolerability of single doses of AZD4144 in healthy participants.
Time frame: From Screening (Day -28 to Day -2) to Day 25