Healthy SubjectsPhase 1NCT05551897
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
A Phase 1 study testing Camizestrant and Itraconazole in people with Healthy Subjects, run by AstraZeneca at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Camizestrant and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2022to 28 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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).
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- 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.
- Subject has been previously hospitalized with COVID-19 infection within the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Subjects
- Being tested
- Camizestrant, Itraconazole
- Keywords
- Pharmacokinetics, Breast Cancer, Selective Estrogen Receptor Degrader (SERD), ER-Positive, HER2- Negative Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamizestrantDrug
Also called AZD9833
Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.
ItraconazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Camizestrant; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant
To assess the effect of Itraconazole on AUCinf of Camizestrant.
Measured: 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.
Measured: 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.
Measured: 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)
Safety and tolerability of Camizestrant alone and in combination with Itraconazole will be assessed.
Measured: 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)
Number of subjects who discontinue the study drug due to adverse events will be assessed.
Measured: From Day 1 (period 1) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start4 Oct 2022
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551897
- Sponsor's protocol ID
- D8532C00003
- Other IDs
- 2022-002011-35
- Status last verified
- Jan 2023
- First submitted
- 20 Sep 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05551897
- Acronym / sponsor ID
- D8532C00003
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Breast Cancer, Selective Estrogen Receptor Degrader (SERD), ER-Positive, HER2- Negative Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Camizestrant, Drug: ItraconazoleSubjects 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamizestrantAlso: AZD9833Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3. | Drug | Treatment Arm |
| ItraconazoleSubjects 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. | Drug | Treatment Arm |
Primary outcome
Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant
Time frame: Day 1 to Day 4 (Period 1 and Period 3)
To assess the effect of Itraconazole on AUCinf of Camizestrant.
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of Camizestrant
Time frame: Day 1 to Day 4 (Period 1 and Period 3)
To assess the effect of Itraconazole on AUClast of Camizestrant.
Maximum observed plasma (peak) drug concentration (Cmax) of Camizestrant
Time frame: Day 1 to Day 4 (Period 1 and Period 3)
To assess the effect of Itraconazole on Cmax of Camizestrant.
2 secondary outcomes
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
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]
Number of subjects with adverse events leading to the discontinuation of study drug (DAEs)
Time frame: From Day 1 (period 1) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Camizestrant and Itraconazole in people with Healthy Subjects, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant (time frame: Day 1 to Day 4 (Period 1 and Period 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.