A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole

• Status: Not yet recruiting
• Trial end date: 2022-11-28
• Target enrollment: 0
• Participant gender: Female

Summary

This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel
• Treatments: Itraconazole

Criteria

Inclusion Criteria:

• Healthy post-menopausal female subjects aged 50 to 70 years with suitable veins for cannulation or repeated venipuncture

• Subjects must be post-menopausal by fulfilling the following criterion:

a. Post-menopausal defined as amenorrhea for at least 12 months or more without an alternative medical or surgical cause and confirmed by an FSH result of ≥ 30 IU/L.

• Have a body mass index (BMI) between 19 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

• Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) from screening, and for 2 weeks after last administration of the study drug.

Exclusion Criteria:

• History of any clinically significant disease or disorder which may either put the subject at risk because of participation 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.

• History of clinically significant cardiovascular, chronic respiratory, neurological, or psychiatric disorder

• History of or ongoing clinically significant visual disturbances including but not limited to visual hallucinations, migraine with visual symptoms, blurred vision, frequent floaters/flashes associated with other symptoms such as dizziness

• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.

• Any clinically significant abnormal findings in vital signs or 12-lead Electrocardiogram (ECG).

• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human Immunodeficiency Virus (HIV) antibody.

• Known or suspected history of drug or alcohol abuse.

• History of significant allergy or hypersensitivity.

• Current smokers or those who have smoked or used nicotine products (including e-cigarettes and nicotine replacement products) within the 3 months prior to screening.

• Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to first dose in the study.

• Have any active indication for therapeutic anticoagulation, and/or having taken an anticoagulant within 14 days of beginning the study.

• Any of the following signs or confirmation of COVID-19 infection:

1. Subject has a positive test for SARS-CoV-2 prior to admission.

2. Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnoea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or at admission.

3. Subject has been previously hospitalized with COVID-19 infection within the last 12 months.