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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

NCT06948006

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: AZD4144, Omeprazole

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. History of any clinically important disease or disorder that may put the participant at risk or influence study results.
2. History or presence of gastrointestinal, hepatic, or renal disease or any condition affecting drug absorption, distribution, metabolism, or excretion.
3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of randomization.
4. Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever within 14 days prior to dosing.
5. Clinically significant serious active and chronic infections within 60 days prior to randomization.
6. Any history or evidence of tuberculosis (TB) (active or latent) using TB-QuantiFERON tests during screening.
7. Clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19).
8. Known history of primary immunodeficiency or an underlying condition that predisposes to infection.
9. Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV).
10. 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.
11. Participants who have previously received AZD4144.

Locations (1)

Harrow, United Kingdom