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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AZD4144; Drug: Omeprazole

Detailed Description

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
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144	To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution.; 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.; To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.	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	To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution.; 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.; To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.	Days 1-4, Days 8-11 and Days 15-18
Maximum observed drug concentration (Cmax) of AZD4144	To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution.; 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.; To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.	Days 1-4, Days 8-11 and Days 15-18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	To assess the safety and tolerability of single doses of AZD4144 in healthy participants.	From Day 1 to Day 25
Number of participants with serious AEs	To assess the safety and tolerability of single doses of AZD4144 in healthy participants.	From Screening (Day -28 to Day -2) to Day 25

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Actual): June 27, 2025
• Study Completion (Actual): June 27, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Food effect; Proton-pump inhibitor; Tablet formulation; Cardiorenal disease
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: D9441C00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No