A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants

NCT06925854 | Completed Phase 1

• 1 other identifier: D9441C00002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Nucleotide-binding domain,; leucine-rich-containing family, pyrindomain-containing-3 (NLRP3) inflammasome; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Day 1 to Day 4 and Day 10 to Day 13

Secondary Outcomes (1)

• Number of participants with adverse events

  From screening (Day-28 to Day -2) until Follow-up (Day 20)

Study Arms (2)

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).

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).

Drug: AZD4144; Drug: Rosuvastatin

Interventions

AZD4144 DRUG

Oral tablet of AZD4144 will be administered.

Treatment sequence AB; Treatment sequence BA

Rosuvastatin DRUG

Oral tablet of rosuvastatin will be administered.

Treatment sequence AB; Treatment sequence BA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 7, 2025
• First Posted: April 13, 2025
• Study Start: April 17, 2025
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 researchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)