A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Partic… (NCT06925854) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants
United Kingdom12 participantsStarted 2025-04-17
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Timeframe: Day 1 to Day 4 and Day 10 to Day 13
2
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast)