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

NCT ID: NCT05551897

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2022-12-28

Brief 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.

Detailed 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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: EXPERIMENTAL

Camizestrant

Intervention Type: DRUG

Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.

Itraconazole

Intervention Type: DRUG

Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3.

Interventions

Camizestrant

Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.

Intervention Type: DRUG

Itraconazole

Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3.

Intervention Type: DRUG

Other Intervention Names

AZD9833

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

2022-002011-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D8532C00003

Identifier Type: -

Identifier Source: org_study_id