a study to assess the pharmacokinetics of camizestrant (azd9833) when administered alone and in combination with itraconazole

Conditions: Healthy Subjects

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.

this open-label, fixed sequence study will comprise of: * a screening period of 28 days; * a fixed sequence of three treatment period: treatment period 1: camizestrant only, treatment period 2: itraconazole only, treatment period 3: camizestrant and itraconazole in combination. • a follow-up visit at 7 to 14 days after the last camizestrant pk sample in period 3. there will be a washout period of 7 to 10 days between period 1 and period 2. each subject will be involved in the study for approximately 8 or 9 weeks.

Eligibility 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.

Keywords: pharmacokinetics breast cancer selective estrogen receptor degrader (serd) er-positive, her2- negative breast cancer