ER-positive, HER2-negative Breast CancerPhase 1NCT05364255
A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833
A Phase 1 study testing [14C]AZD9833 Oral Solution, 75 mg in people with ER-positive, HER2-negative Breast Cancer, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer. This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. 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
- ER-positive, HER2-negative Breast Cancer
- What is being tested?
- [14C]AZD9833 Oral Solution, 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2022to 20 Jun 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
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Aged between 50 to 70 years inclusive at the time of signing informed consent
- Healthy post-menopausal females, defined as post-menopausal by fulfilling the following criterion:
- amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and without an alternative medical or surgical cause and confirmed by an FSH result of ≥30 IU/L
- Must be willing and able to communicate and participate in the whole study
- Have a body mass index (BMI) between 19.0 to 35.0 kg/m2, weigh at least 50 kg and no more than 100 kg inclusive as measured at screening.
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History or presence of GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP
- 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 abnormalities in clinical chemistry, haematology, or urinalysis results, at screening as judged by the Investigator
- Any clinically significant abnormal findings in vital signs at screening as judged by the Investigator, including systolic BP <100 mmHg, diastolic BP <50 mmHg or heart rate <50 bpm. Vital signs outside these limits can be repeated once for confirmation
Show all 34Show fewer
- Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the Investigator, including non-sinus rhythms, PR interval <120 msec or >220 msec, ventricular rate <50 bpm or >100 bpm, QRS interval >120 msec, or QTcF >470 msec as a mean of triplicate. ECGs can be repeated once in triplicate if parameters are outside these limits for confirmation
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <60 mL/min/1.73m2 using the Cockcroft-Gault equation
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and human immunodeficiency virus (HIV) 1 and 2 antibodies
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 4 weeks prior to Day 1, or less than 5 elimination half-lives + 6 days prior to Day 1, whichever is longer. Note: subjects consented and screened, but not administered IMP in this study or a previous Phase I study, are not excluded
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9833. Hay fever is allowed unless it is active
- Any known or suspected hypersensitivity or contraindication to the components of the study drug, AZD9833, judged to be clinically relevant by the investigator
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening
- A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Positive screen for drugs of abuse at screening or on each admission to the study centre
- Regular alcohol consumption >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or admission
- Subjects who are taking, or have taken:
- any prescribed or over-the-counter drug (other than up to 4 g of paracetamol per day ) or herbal remedies in the 14 days before IMP administration or longer if the medication has a long half-life. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply, as determined by the Investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study
- atropine or atropine containing drugs, in the 14 days before IMP administration
- Systemic oestrogen-containing hormone replacement therapy in the 6 months prior to IMP administration
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks or 5 half-lives (whichever is longer) or any drugs with a known risk, potential risk or conditional risk for QTca prolongation as defined and outlined in the Credible Meds website within 4 weeks prior to Day 1
- Subjects who do not agree to avoid the to use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) for 2 weeks after administration of IMP
- Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the Investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the clinical unit
- Involvement of any Astra Zeneca, Quotient or study site employee or their close relatives
- Subjects who report to have previously received AZD9833 in the last 12 months
- Judgment by the Investigator that the volunteer should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements
- Evidence of current SARS-CoV-2 infection
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening
- Subjects with an anticipated need for major surgery and/or any surgery requiring general anaesthesia during the participation in the study (which may entail administration of atropine in an anaesthetic context)
- Failure to satisfy the Investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Single-Dose, Single-Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833 After Oral Administration in Healthy Post-Menopausal Female Subjects
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site, and will consist of a single study period involving up to 6 post-menopausal female volunteers, aged between 50 to 70 years.
Read the detailed description
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
Breast cancer is the second most common type of cancer in the UK and worldwide. Most women diagnosed with breast cancer are over the age of 50, but younger women and men can also get breast cancer. AZD9833 has the potential to prevent ER activity and increase overall survival in advanced breast cancer patients.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site, and will consist of a single study period involving up to 6 post-menopausal female volunteers, aged between 50 to 70 years.
On Day 1, volunteers will receive a 75 mg dose of [14C]AZD9833 oral solution in the fasted state (on an empty stomach).
Volunteer's blood, urine and faeces will be taken throughout the study for analysis of the test medicine and it's breakdown products (metabolites) and for volunteer safety.
Volunteers will remain in the clinical unit until Day 8, however if the relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinic until Day 10. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required.
Volunteers are expected to be involved in this study for approximately 6 weeks from screening to discharge.
- Conditions
- ER-positive, HER2-negative Breast Cancer
- Being tested
- [14C]AZD9833 Oral Solution, 75 mg
- Keywords
- 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.
[14C]AZD9833 Oral Solution, 75 mgDrug
Oral Solution, 75 mg (NMT 0.67 MBq) - oral, fasted
| Study group | Role | What they receive |
|---|---|---|
| [14C]AZD9833 (D8532C00005) | Experimental | Oral Solution, 75 mg (NMT 0.67 MBq) Receives: Drug: [14C]AZD9833 Oral Solution, 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative amount of AZD9833 excreted (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD9833 excreted
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Assessment of the total radioactivity, expressed as a percentage, by measuring the cumulative amount of AZD9833 excreted
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Plasma samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Urine samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Faeces samples collected from pre-dose until 168 hours post-dose
Secondary outcomes (20)
The amount of total radioactivity eliminated in urine (Ae)
Assessment of the total radioactivity, by measuring the amount of AZD9833 excreted in urine by interval
Measured: Urine samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in urine expressed as a percentage of the radioactive dose administered (%Ae)
Assessment of the total radioactivity, expressed as a percentage, by measuring the amount of AZD9833 excreted in urine by interval
Measured: Urine samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in urine (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD9833 excreted in faeces.
Measured: Urine samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in urine, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Assessment of the total radioactivity, expressed as a percentage, by measuring the cumulative amount of AZD9833 excreted in urine
Measured: Urine samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in faeces (Ae)
Assessment of the total radioactivity, by measuring the amount of AZD9833 excreted in faeces by interval
Measured: Faeces samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in faeces expressed as a percentage of the radioactive dose administered (%Ae)
Assessment of the total radioactivity, expressed as a percentage, by measuring the amount of AZD9833 excreted in faeces by interval
Measured: Faeces samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in faeces (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD9833 excreted in faeces.
Measured: Faeces samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in faeces, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Assessment of the total radioactivity, expressed as a percentage, by measuring the cumulative amount of AZD9833 excreted in faeces
Measured: Faeces samples collected from pre-dose until 168 hours post-dose
Time to maximum concentration (tmax) for AZD9833 and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the time to maximum concentration (tmax)
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Maximum observed concentration (cmax) for AZD9833 and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the maximum observed concentration (cmax)
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD9833 and total radioactivity (AUC0-t)
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the area under the curve from time 0 to the time of last measurable concentration
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD9833 and total radioactivity (AUC0-inf)
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the area under the curve from time 0 extrapolated to infinity
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extr) and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Terminal elimination half-life for AZD9833 (t1/2) and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the terminal elimination half-life
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD9833 (λz) and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the First order rate constant associated with the terminal (log-linear) portion of the curve
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Total body clearance calculated after a single extravascular administration for AZD9833 (CL/F) and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the total body clearance calculated after a single extravascular administration
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Apparent volume of distribution based on the terminal phase for AZD9833 (Vz/F) and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the apparent volume of distribution based on the terminal phase
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Renal clearance for AZD9833 (CLr) and total radioactivity
Assessment of pharmacokinetics of AZD9833 and total radioactivity by measuring the renal clearance
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Assessment of total radioactivity in whole blood and plasma
Measured: Collection of blood samples until 168 hours post dose
Number of AE's experienced by subjects
Safety and tolerability assessed through the incidence of AEs
Measured: AEs recorded from the time of informed consent until the follow up visit (approx 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start10 May 2022
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER-positive, HER2-negative Breast CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364255
- Sponsor's protocol ID
- D8532C00005
- Other IDs
- 2022-000834-40
- Status last verified
- Jun 2024
- First submitted
- 4 May 2022
- Last updated
- 21 Jun 2024
- 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single-Dose, Single-Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833 After Oral Administration in Healthy Post-Menopausal Female Subjects
- ClinicalTrials.gov ID
- NCT05364255
- Acronym / sponsor ID
- D8532C00005
- Conditions
- ER-positive, HER2-negative Breast Cancer
- Keywords
- Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 10 May 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 6 May 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.
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site, and will consist of a single study period involving up to 6 post-menopausal female volunteers, aged between 50 to 70 years.
Detailed description
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
Breast cancer is the second most common type of cancer in the UK and worldwide. Most women diagnosed with breast cancer are over the age of 50, but younger women and men can also get breast cancer. AZD9833 has the potential to prevent ER activity and increase overall survival in advanced breast cancer patients.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site, and will consist of a single study period involving up to 6 post-menopausal female volunteers, aged between 50 to 70 years.
On Day 1, volunteers will receive a 75 mg dose of [14C]AZD9833 oral solution in the fasted state (on an empty stomach).
Volunteer's blood, urine and faeces will be taken throughout the study for analysis of the test medicine and it's breakdown products (metabolites) and for volunteer safety.
Volunteers will remain in the clinical unit until Day 8, however if the relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinic until Day 10. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required.
Volunteers are expected to be involved in this study for approximately 6 weeks from screening to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]AZD9833 (D8532C00005) | Experimental | Drug: [14C]AZD9833 Oral Solution, 75 mgOral Solution, 75 mg (NMT 0.67 MBq) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Aged between 50 to 70 years inclusive at the time of signing informed consent
- Healthy post-menopausal females, defined as post-menopausal by fulfilling the following criterion:
- Must be willing and able to communicate and participate in the whole study
- Have a body mass index (BMI) between 19.0 to 35.0 kg/m2, weigh at least 50 kg and no more than 100 kg inclusive as measured at screening.
Key exclusion criteria (34 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History or presence of GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP
- 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 abnormalities in clinical chemistry, haematology, or urinalysis results, at screening as judged by the Investigator
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 |
|---|---|---|
| [14C]AZD9833 Oral Solution, 75 mgOral Solution, 75 mg (NMT 0.67 MBq) - oral, fasted | Drug | [14C]AZD9833 (D8532C00005) |
Primary outcome
The cumulative amount of AZD9833 excreted (CumAe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the cumulative amount of AZD9833 excreted
The cumulative amount of AZD9833 excreted, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity, expressed as a percentage, by measuring the cumulative amount of AZD9833 excreted
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Plasma samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Urine samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Faeces samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
20 secondary outcomes
The amount of total radioactivity eliminated in urine (Ae)
Time frame: Urine samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in urine expressed as a percentage of the radioactive dose administered (%Ae)
Time frame: Urine samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in urine (CumAe)
Time frame: Urine samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in urine, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Time frame: Urine samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in faeces (Ae)
Time frame: Faeces samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in faeces expressed as a percentage of the radioactive dose administered (%Ae)
Time frame: Faeces samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in faeces (CumAe)
Time frame: Faeces samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in faeces, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Time frame: Faeces samples collected from pre-dose until 168 hours post-dose
Time to maximum concentration (tmax) for AZD9833 and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Maximum observed concentration (cmax) for AZD9833 and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD9833 and total radioactivity (AUC0-t)
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD9833 and total radioactivity (AUC0-inf)
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extr) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Terminal elimination half-life for AZD9833 (t1/2) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD9833 (λz) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Total body clearance calculated after a single extravascular administration for AZD9833 (CL/F) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Apparent volume of distribution based on the terminal phase for AZD9833 (Vz/F) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Renal clearance for AZD9833 (CLr) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Time frame: Collection of blood samples until 168 hours post dose
Number of AE's experienced by subjects
Time frame: AEs recorded from the time of informed consent until the follow up visit (approx 6 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 21 Jun 2024.
- Redacted CSR SynopsisLink provided by the sponsor.
- 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Recruiting
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Breast Neoplasms, Carcinoma, Ductal, Breast
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
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.
Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM principal investigator
Quotient Sciences
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 [14C]AZD9833 Oral Solution, 75 mg in people with ER-positive, HER2-negative Breast Cancer, 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 7 inclusion and 34 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 21 Jun 2024. 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?
The cumulative amount of AZD9833 excreted (CumAe) (time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose). The study lists 5 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 21 Jun 2024.