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 | Completed Phase 1

• 1 other identifier: D9441C00003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144

  1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. 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. 3. 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

  1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. 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. 3. 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

  1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. 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. 3. 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 Outcomes (2)

• Number of participants with adverse events (AEs)

  From Day 1 to Day 25

• Number of participants with serious AEs

  From Screening (Day -28 to Day -2) to Day 25

Study Arms (2)

Arm 1: AZD4144

EXPERIMENTAL

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

Arm 2: AZD4144 + Omeprazole

EXPERIMENTAL

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; Drug: Omeprazole

Interventions

AZD4144 DRUG

Participants will receive AZD4144 orally.

Arm 1: AZD4144; Arm 2: AZD4144 + Omeprazole

Omeprazole DRUG

Participants will receive omeprazole orally.

Arm 2: AZD4144 + Omeprazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 28, 2025
• Study Start: April 23, 2025
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

GB (1)