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Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants

Not Yet RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Healthy

Interventions: AZD4144, AZD4144, Itraconazole

The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
2. Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
3. 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.
4. 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.

Exclusion Criteria:

1. Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
2. History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
3. Any clinically important illness, medical/surgical procedure, or trauma.
4. Active systemic bacterial, viral, or fungal infection.
5. Clinically significant serious active or chronic infections.
6. Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
7. Concomitant immunosuppressive, steroid treatment.
8. Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.
9. Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.
10. Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).