CClinicalTrials.gg
Sign In
CompletedNCT05551897Updated Jan 6, 2023

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

A Phase 1 interventional study of Camizestrant and Itraconazole in Healthy Subjects, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-06.

Sponsored by AstraZeneca · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
50 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Pharmacokinetics
  • Breast Cancer
  • Selective Estrogen Receptor Degrader (SERD)
  • ER-Positive, HER2- Negative Breast Cancer
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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.

    Drug: Camizestrant · Drug: Itraconazole

Interventions

  • DrugCamizestrant

    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

  • DrugItraconazole

    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.

06

What researchers measure

Primary outcomes

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

    To assess the effect of Itraconazole on AUCinf of Camizestrant.

    Time frame: Day 1 to Day 4 (Period 1 and Period 3)

  2. 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.

    Time frame: Day 1 to Day 4 (Period 1 and Period 3)

  3. Maximum observed plasma (peak) drug concentration (Cmax) of Camizestrant

    To assess the effect of Itraconazole on Cmax of Camizestrant.

    Time frame: Day 1 to Day 4 (Period 1 and Period 3)

Secondary outcomes

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

    Safety and tolerability of Camizestrant alone and in combination with Itraconazole will be assessed.

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

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

    Number of subjects who discontinue the study drug due to adverse events will be assessed.

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

07

Study locations

1 site
  • Research Site
    Harrow, HA1 3UJ, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05551897
Lead sponsor
AstraZeneca
Collaborators
Parexel
Responsible party
Sponsor
First posted
Sep 23, 2022
Start date
Oct 4, 2022
Primary completion
Dec 28, 2022
Completion
Dec 28, 2022
Last update
Jan 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

AstraZeneca

Start the discussion