HealthyPhase 1NCT06925854
A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants
A Phase 1 study testing AZD4144 and Rosuvastatin in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of rosuvastatin when administered alone and in combination with single oral dose of AZD4144. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD4144 and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Apr 2025to 12 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index between 18 and 32 kg/m2 inclusive at the Screening Visit and on first admission (Visit 2) to the Clinical Unit and weigh at least 45 kg.
- All females must have a negative pregnancy test at the Screening Visit.
- Female participants of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Clinically significant serious active and chronic infections within 60 days prior to randomisation.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the randomisation.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever (confirmed tympanic body temperature > 37.5 °C) within 14 days prior to dosing on Day 1 depending on experienced symptoms.
- Bacillus Calmette-Guérin vaccine within one year prior to signing the ICF.
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- Any laboratory values with deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated at the discretion of the Investigator: alanine transaminase (ALT) >1.00 × Upper Limit Normal (ULN), aspartate transaminase (AST) > 1.00 ×ULN, white blood cell count < Lower limit normal (LLN), differential neutrophils < LLN, bilirubin > 1.00 × ULN, eGlomerular filtration rate (eGFR) < 60 mL/min/1.73 m² calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (eGFR will only be assessed at Screening).
- Any positive result at Screening for serum hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus.
- Has received any investigational medicinal product.
- Participants who have previously received AZD4144.
- Participants with myopathy, defined as muscle weakness that in opinion of the investigator, enhances the participant's risk of developing statin-associated muscle symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, 2-period, 2-sequence Cross-over Study to Assess the Effect of AZD4144 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of rosuvastatin when administered alone and in combination with single oral dose of AZD4144.
Read the detailed description
This is a Phase 1, randomized, open label study in healthy participants.
The participants will be provided with:
Treatment A: single dose of rosuvastatin Treatment B: single dose of rosuvastatin in combination with AZD4144. The participants will be randomized in the 1:1 ratio to either receive treatment sequence AB or sequence BA.
The study will be comprised of:
- A screening period of 28 days.
- Two treatment periods (Treatment period 1 and Treatment period 2) of 4 days each where participants will receive the study intervention on Day 1 in Treatment period 1 and on Day 10 in Treatment period 2.
- A final Follow-up visit between Day 17 and Day 20.
- Conditions
- Healthy
- Being tested
- AZD4144, Rosuvastatin
- Keywords
- Nucleotide-binding domain,, leucine-rich-containing family, pyrindomain-containing-3 (NLRP3) inflammasome, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
Oral tablet of AZD4144 will be administered.
RosuvastatinDrug
Oral tablet of rosuvastatin will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence AB | Experimental | Participants will receive single dose of rosuvastatin under fasted condition (Treatment A), followed by a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B). Receives: Drug: AZD4144; Drug: Rosuvastatin |
| Treatment sequence BA | Experimental | Participants will receive a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B), followed by a single dose of rosuvastatin under fasted condition (Treatment A). Receives: Drug: AZD4144; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from 0 to infinity (AUCinf)
The AUCinf of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
Measured: Day 1 to Day 4 and Day 10 to Day 13
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast)
The AUClast of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
Measured: Day 1 to Day 4 and Day 10 to Day 13
Maximum plasma drug concentration (Cmax)
The Cmax of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
Measured: Day 1 to Day 4 and Day 10 to Day 13
Secondary outcomes (1)
Number of participants with adverse events
The safety and the tolerability of AZD4144 in combination with rosuvastatin will be evaluated.
Measured: From screening (Day-28 to Day -2) until Follow-up (Day 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start17 Apr 2025
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925854
- Sponsor's protocol ID
- D9441C00002
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2025
- Last updated
- 18 Jun 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. 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 shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 2-period, 2-sequence Cross-over Study to Assess the Effect of AZD4144 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT06925854
- Acronym / sponsor ID
- D9441C00002
- Conditions
- Healthy
- Keywords
- Nucleotide-binding domain,, leucine-rich-containing family, pyrindomain-containing-3 (NLRP3) inflammasome, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 13 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 purpose of this study is to evaluate the pharmacokinetics (PK) of rosuvastatin when administered alone and in combination with single oral dose of AZD4144.
Detailed description
This is a Phase 1, randomized, open label study in healthy participants.
The participants will be provided with:
Treatment A: single dose of rosuvastatin Treatment B: single dose of rosuvastatin in combination with AZD4144. The participants will be randomized in the 1:1 ratio to either receive treatment sequence AB or sequence BA.
The study will be comprised of:
- A screening period of 28 days.
- Two treatment periods (Treatment period 1 and Treatment period 2) of 4 days each where participants will receive the study intervention on Day 1 in Treatment period 1 and on Day 10 in Treatment period 2.
- A final Follow-up visit between Day 17 and Day 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence AB | Experimental | Drug: AZD4144, Drug: RosuvastatinParticipants will receive single dose of rosuvastatin under fasted condition (Treatment A), followed by a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B). |
| Treatment sequence BA | Experimental | Drug: AZD4144, Drug: RosuvastatinParticipants will receive a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B), followed by a single dose of rosuvastatin under fasted condition (Treatment A). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a body mass index between 18 and 32 kg/m2 inclusive at the Screening Visit and on first admission (Visit 2) to the Clinical Unit and weigh at least 45 kg.
- All females must have a negative pregnancy test at the Screening Visit.
- Female participants of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
Key exclusion criteria (11 listed)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Clinically significant serious active and chronic infections within 60 days prior to randomisation.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the randomisation.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever (confirmed tympanic body temperature > 37.5 °C) within 14 days prior to dosing on Day 1 depending on experienced symptoms.
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 |
|---|---|---|
| AZD4144Oral tablet of AZD4144 will be administered. | Drug | Treatment sequence AB, Treatment sequence BA |
| RosuvastatinOral tablet of rosuvastatin will be administered. | Drug | Treatment sequence AB, Treatment sequence BA |
Primary outcome
Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Time frame: Day 1 to Day 4 and Day 10 to Day 13
The AUCinf of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 4 and Day 10 to Day 13
The AUClast of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
Maximum plasma drug concentration (Cmax)
Time frame: Day 1 to Day 4 and Day 10 to Day 13
The Cmax of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
1 secondary outcome
Number of participants with adverse events
Time frame: From screening (Day-28 to Day -2) until Follow-up (Day 20)
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 18 Jun 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. 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 shared
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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 Rosuvastatin in people with Healthy, 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 5 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 18 Jun 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 plasma concentration-time curve from 0 to infinity (AUCinf) (time frame: Day 1 to Day 4 and Day 10 to Day 13). 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 18 Jun 2025.