Clinical trial · Interventional
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
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
NCT05551897CI-TRIAL-00063052completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Subjects | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camizestrant | Drug | Camizestrant | ALIAS |
| Itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- 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.
- interventionNames
- Drug: Camizestrant
- Drug: Itraconazole
Primary outcomes (3)
- measure
- Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant
- timeFrame
- Day 1 to Day 4 (Period 1 and Period 3)
- description
- To assess the effect of Itraconazole on AUCinf of Camizestrant.
- measure
- Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of Camizestrant
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.