Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants
Starting soon · Phase 1
Conditions studied: Healthy
In brief
The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.
Key facts
- Study ID
- NCT07685600
- Run by
- AstraZeneca
- People needed
- 32
- Starts
- 2026-07-30
- Expected to finish
- 2026-10-28
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.
- Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.
You may not qualify if…
- Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
- History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Active systemic bacterial, viral, or fungal infection.
- Clinically significant serious active or chronic infections.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- Concomitant immunosuppressive, steroid treatment.
- Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.
- Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.
- Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Full record on ClinicalTrials.gov
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