Investigating how food and omeprazole affect the absorption of AZD4144 in healthy participants

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

This study is testing how food and the medication omeprazole affect how well a new drug called AZD4144 is absorbed in healthy people.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Harrow)
• Trial ID: NCT06948006 on ClinicalTrials.gov

What this trial studies

This study aims to compare the pharmacokinetics of two different formulations of AZD4144 and evaluate how food intake and the proton-pump inhibitor omeprazole influence its absorption in healthy individuals. It is designed as an open-label, randomized, single-dose, crossover Phase I study. Participants will undergo a screening period followed by three residential periods where they will receive various treatments under different conditions. The study will also include a follow-up period to monitor participants after the last dose.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male and female participants aged 18-65 with a BMI between 18-32 kg/m2.

Not a fit: Patients with a history of gastrointestinal, hepatic, or renal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of how different factors affect the absorption of AZD4144, potentially leading to improved dosing strategies.

How similar studies have performed: Other studies have shown success in evaluating pharmacokinetics with similar methodologies, indicating that this approach is well-established.

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.

Where this trial is running

Harrow

• Research Site — Harrow, United Kingdom (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Cardiorenal disease; Food effect; Proton-pump inhibitor; Pharmacokinetics; Tablet formulation