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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Itraconazole; Drug: Camizestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05551897

D8532C00003

2022-002011-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Subjects will receive a single oral dose of Camizestrant on Day 1 of treatment period 1. Following washout period of 7 to 10 days, subjects will receive Itraconazole on Days 1, 2, and 3 of treatment period 2, and single oral dose of Camizestrant plus a dose of Itraconazole on Day 1, followed by Itraconazole alone on Day 2 and Day 3 of treatment period 3.

Treatment:

Drug: Itraconazole

Drug: Camizestrant