Healthy ParticipantsPhase 1NCT06948006
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
A Phase 1 study testing AZD4144 and Omeprazole in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD4144 and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2025to 27 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This is an open-label, randomized, single-dose, crossover Phase I study.
The study will comprise:
- A Screening Period of 28 days.
- Three Residential Periods
- 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:
- Treatment A: AZD4144 dose 1 as tablet (under fasted condition)
- Treatment B: AZD4144 dose 1 as tablet (under fed condition)
- Treatment C: AZD4144 dose 1 as an oral solution (under fasted condition)
Arm 2 consists of 3 treatments:
- Treatment D: AZD4144 dose 2 as tablet (under fasted condition)
- Treatment E: AZD4144 dose 2 as tablet (under fed condition)
- 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
- Conditions
- Healthy Participants
- Being tested
- AZD4144, Omeprazole
- Keywords
- Cardiorenal disease, Food effect, Proton-pump inhibitor, Pharmacokinetics, Tablet formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
Participants will receive AZD4144 orally.
OmeprazoleDrug
Participants will receive omeprazole orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: AZD4144; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Days 1-4, Days 8-11 and Days 15-18
Secondary outcomes (2)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of single doses of AZD4144 in healthy participants.
Measured: 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.
Measured: From Screening (Day -28 to Day -2) to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2025
- Study start23 Apr 2025
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948006
- Sponsor's protocol ID
- D9441C00003
- Status last verified
- Jul 2025
- First submitted
- 22 Apr 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06948006
- Acronym / sponsor ID
- D9441C00003
- Conditions
- Healthy Participants
- Keywords
- Cardiorenal disease, Food effect, Proton-pump inhibitor, Pharmacokinetics, Tablet formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 28 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, randomized, single-dose, crossover Phase I study.
The study will comprise:
- A Screening Period of 28 days.
- Three Residential Periods
- 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:
- Treatment A: AZD4144 dose 1 as tablet (under fasted condition)
- Treatment B: AZD4144 dose 1 as tablet (under fed condition)
- Treatment C: AZD4144 dose 1 as an oral solution (under fasted condition)
Arm 2 consists of 3 treatments:
- Treatment D: AZD4144 dose 2 as tablet (under fasted condition)
- Treatment E: AZD4144 dose 2 as tablet (under fed condition)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: AZD4144 | Experimental | Drug: AZD4144Participants 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. |
| Arm 2: AZD4144 + Omeprazole | Experimental | Drug: AZD4144, Drug: OmeprazoleParticipants 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4144Participants will receive AZD4144 orally. | Drug | Arm 1: AZD4144, Arm 2: AZD4144 + Omeprazole |
| OmeprazoleParticipants will receive omeprazole orally. | Drug | Arm 2: AZD4144 + Omeprazole |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144
Time frame: Days 1-4, Days 8-11 and Days 15-18
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.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD4144
Time frame: Days 1-4, Days 8-11 and Days 15-18
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.
Maximum observed drug concentration (Cmax) of AZD4144
Time frame: Days 1-4, Days 8-11 and Days 15-18
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.
2 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: From Day 1 to Day 25
Number of participants with serious AEs
Time frame: From Screening (Day -28 to Day -2) to Day 25
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4144 and Omeprazole in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144 (time frame: Days 1-4, Days 8-11 and Days 15-18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.