A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants

This is an open-label, randomized, single-dose, crossover Phase I study.

The study will comprise:

• A Screening Period of 28 days.
• Three Residential Periods
• 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:

• Treatment A: AZD4144 dose 1 as tablet (under fasted condition)
• Treatment B: AZD4144 dose 1 as tablet (under fed condition)
• Treatment C: AZD4144 dose 1 as an oral solution (under fasted condition)

Arm 2 consists of 3 treatments:

• Treatment D: AZD4144 dose 2 as tablet (under fasted condition)
• Treatment E: AZD4144 dose 2 as tablet (under fed condition)
• 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

Inclusion criteria

• Signed the informed consent form before any study-related procedure.
• Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
• Negative pregnancy test for females at screening, first admission, and follow-up.
• Females of childbearing potential must use highly effective contraception from first dose until 3 months after last dose.
• Non-childbearing potential females must meet postmenopausal or surgical sterilization criteria.
• Sexually active fertile males must use contraception from first dose until 3 months after last dose.
• Body Mass Index (BMI) between 18-32 kg/m2 and weight ≥45 kg at screening and first admission.

Exclusion criteria

• History of any clinically important disease or disorder that may put the participant at risk or influence study results.
• History or presence of gastrointestinal, hepatic, or renal disease or any condition affecting drug absorption, distribution, metabolism, or excretion.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of randomization.
• Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever within 14 days prior to dosing.
• Clinically significant serious active and chronic infections within 60 days prior to randomization.
• Any history or evidence of tuberculosis (TB) (active or latent) using TB-QuantiFERON tests during screening.
• Clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19).
• Known history of primary immunodeficiency or an underlying condition that predisposes to infection.
• Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV).
• Plasma donation within one month of the screening visit or any blood donation/blood loss > 500 mL during the 3 months prior to the screening visit.
• Participants who have previously received AZD4144.