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

NCT05551897 | Completed Phase 1

• 2 other identifiers: D8532C000032022-002011-35
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Pharmacokinetics; Breast Cancer; Selective Estrogen Receptor Degrader (SERD); ER-Positive, HER2- Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant

  To assess the effect of Itraconazole on AUCinf of Camizestrant.

  Day 1 to Day 4 (Period 1 and Period 3)

• Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of Camizestrant

  To assess the effect of Itraconazole on AUClast of Camizestrant.

  Day 1 to Day 4 (Period 1 and Period 3)

• Maximum observed plasma (peak) drug concentration (Cmax) of Camizestrant

  To assess the effect of Itraconazole on Cmax of Camizestrant.

  Day 1 to Day 4 (Period 1 and Period 3)

Secondary Outcomes (2)

• Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

  From Screening (Day -28 to Day -2) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]

• Number of subjects with adverse events leading to the discontinuation of study drug (DAEs)

  From Day 1 (period 1) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Drug: Camizestrant; Drug: Itraconazole

Interventions

Camizestrant DRUG

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

Also known as: AZD9833

Treatment Arm

Itraconazole 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.

Treatment Arm

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AZD9833; Itraconazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 4, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

GB (1)