A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination… (NCT06846528) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
United States16 participantsStarted 2025-02-26
Plain-language summary
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of non-childbearing potential must be postmenopausal for at least 12 months or have documentation of irreversible surgical sterilization.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg.
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.
* 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 first administration of study intervention.
* Abnormal laboratory values, clinically important abnormalities or abnormal vital signs
* Any positive result on screening for serum Hepatitis B surface antigen/antibody, Hepatitis C, or Human Immunodeficiency Virus.
* Current smokers (within 3 months prior to screening visit) or history of alcohol and drug abuse
* History of severe allergy or hypersensitivity
* Excessive intake of caffeine-contai…
What they're measuring
1
Maximum observed drug concentration (Cmax) of AZD2389
Timeframe: Day 1 to Day 8
2
Area under concentration-timecurve from time zero to infinity (AUCinf) of AZD2389
Timeframe: Day 1 to Day 8
3
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD2389