Clinical trial NCT06925854: A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Nucleotide-binding domain,
leucine-rich-containing family, pyrindomain-containing-3 (NLRP3) inflammasome
Inflammation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Area under plasma concentration-time curve from 0 to infinity (AUCinf)
timeFrame: Day 1 to Day 4 and Day 10 to Day 13
measure: Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast)
timeFrame: Day 1 to Day 4 and Day 10 to Day 13
measure: Maximum plasma drug concentration (Cmax)
timeFrame: Day 1 to Day 4 and Day 10 to Day 13
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: From screening (Day-28 to Day -2) until Follow-up (Day 20)
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
References: