Clinical trial NCT05551897: A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics
Breast Cancer
Selective Estrogen Receptor Degrader (SERD)
ER-Positive, HER2- Negative Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2022-09-23
Enrollment: 14
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
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)
measure: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of Camizestrant
timeFrame: Day 1 to Day 4 (Period 1 and Period 3)
measure: Maximum observed plasma (peak) drug concentration (Cmax) of Camizestrant
timeFrame: Day 1 to Day 4 (Period 1 and Period 3)
Secondary outcomes:
measure: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From Screening (Day -28 to Day -2) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]
measure: Number of subjects with adverse events leading to the discontinuation of study drug (DAEs)
timeFrame: From Day 1 (period 1) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
References: