A study to assess the pharmacokinetics of Camizestrant (AZD9833) when Administered Alone and in Combination with Itraconazole

Study identifier:D8532C00003

ClinicalTrials.gov identifier:NCT05551897

EudraCT identifier:2022-002011-35

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Fixed Sequence Study in Healthy Post Menopausal Female Subjects to Assess the Pharmacokinetics of Camizestrant (AZD9833) when Administered Alone and in Combination with Itraconazole

Medical condition

Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Camizestrant, Itraconazole

Sex

Female

Actual Enrollment

Study type

Interventional

Age

50 Years - 70 Years

Date

Study Start Date: 04 Oct 2022

Primary Completion Date: 28 Dec 2022

Study Completion Date: 28 Dec 2022

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Dec 2023 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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:
a. Subject has a positive test for SARS-CoV-2 prior to admission.
b. 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.
c. Subject has been previously hospitalized with COVID-19 infection within the last 12 months.

No locations available

Arms	Assigned Interventions
Experimental: 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.	-

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]