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A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Healthy Participants
Interventions: AZD2389, Itraconazole
Countries: United States
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 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: * 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-containing drinks or food * Use of drugs with enzyme inducing properties or use of any prescribed or nonprescribed medication including antacids, analgesics
Locations (1)
- Brooklyn, Maryland, United States