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

Study identifier:D9441C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

An Open-label, Randomised, 2-arm, 3-period, 6-treatment Single-dose, Crossover Study Comparing the Pharmacokinetics of 2 Different Formulations of AZD4144, and Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4144, Omeprazole

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 23 Apr 2025

Estimated Primary Completion Date: 11 Jul 2025

Estimated Study Completion Date: 11 Jul 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2025 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: Arm 1: AZD4144 Participants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions.	Drug: AZD4144 Participants will receive AZD4144 orally.
Experimental: Arm 2: AZD4144 + Omeprazole Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F).	Drug: AZD4144 Participants will receive AZD4144 orally. Drug: Omeprazole Participants will receive omeprazole orally.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]