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Selective Estrogen Receptor Degrader
Camizestrant for Liver Disease
Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For participant with hepatic impairment: Body weight within 50 to 100 kg and BMI within the range 19.0 to 35.0 kg/m2 (inclusive) as measured at screening.
Female, post-menopausal. (a) Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of study intervention without an alternative medical or surgical cause, confirmed by an FSH result of ≥ 30 IU/L obtained at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 weeks
Awards & highlights
Study Summary
This trial tests a drug on post-menopausal women with normal, moderate or severe liver impairment to see how safe & effective it is.
Who is the study for?
This study is for post-menopausal women aged 50-75 with liver disease, either healthy or with moderate to severe hepatic impairment. Participants must not use certain medications like warfarin and should be in stable health aside from their liver condition. They cannot have a history of drug abuse, significant blood loss recently, or other serious medical conditions.Check my eligibility
What is being tested?
The trial tests the effects of a single dose of Camizestrant (75 mg) on women with different levels of liver function. It's an open-label study where participants are divided into groups based on their liver health to compare how they process the medication.See study design
What are the potential side effects?
While specific side effects for Camizestrant aren't listed here, common ones may include reactions at the injection site, nausea, fatigue, and potential allergic responses due to sensitivity to the drug's components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh between 50 to 100 kg and my BMI is between 19.0 to 35.0.
Select...
I am a woman who has not had a period for 12 months due to menopause.
Select...
I agree not to use warfarin or phenytoin during and for 2 weeks after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK parameters AUCinf.;
PK parameters AUClast
PK parameters CL/F
+5 moreSecondary outcome measures
Number of participants with an AE causally related to IMP leading to study discontinuation
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Group II: Group 2Experimental Treatment1 Intervention
Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
Group III: Group 1Experimental Treatment1 Intervention
Matched-control healthy participants with normal hepatic function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Camizestrant
2023
Completed Phase 1
~40
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,764 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious ongoing infections.I have tested positive for COVID-19 recently.You cannot stop or expect to use:I have a significant thyroid condition.I have a history of HIV or tested positive for hepatitis B or C.I have had liver problems for more than 6 months without getting worse recently.My liver functions normally and I have no significant health issues.I haven't taken HIV protease inhibitors or anticoagulants in the last 14 days.I am mentally capable and do not have significant emotional issues that would affect my participation.I have significant vision problems, including hallucinations or frequent dizziness.I don't have conditions that affect medicine absorption due to stomach surgery.I haven't taken any strong medication that affects liver enzymes or certain drug transporters in the last month.You have had problems with alcohol or drug abuse within the past two years.My kidneys are not working well (creatinine clearance < 60 mL/min).My diabetes is not well-controlled.I have been diagnosed with HIV.I haven't taken acetaminophen or ethacrynic acid in the last 24 hours.I have not donated more than 500 mL of blood or had significant blood loss in the last 56 days.I have not donated plasma in the last 28 days.I haven't taken any medication that affects heart rhythm in the last 4 weeks or longer.You have used drugs recreationally within the past 2 years before the screening.I am currently taking medication, whether prescribed or over-the-counter.Your resting heart rate is too low (less than 50 beats per minute) or too high (more than 99 beats per minute) when lying down.I agree not to use warfarin or phenytoin during and for 2 weeks after the study.You have a special tube called a transjugular intrahepatic portosystemic shunt in your body.You have had an allergic reaction to camizestrant or similar drugs in the past.My liver functions are normal, so I might not qualify.I do not have any major health or mental issues that would affect my participation.I have not had major surgery in the last 30 days.I do not have severe liver problems.My liver works normally and I am matched with someone of similar age who has liver issues.I am between 50 and 75 years old with liver problems.I have liver problems but am in good health otherwise.I weigh between 50 to 100 kg and my BMI is between 19.0 to 35.0.I am a woman who has not had a period for 12 months due to menopause.My liver works normally and my weight matches someone with liver issues within 20%.You are capable of providing written confirmation that you understand the requirements and restrictions outlined in the ICF and this protocol.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my participation in this experiment permissible?
"This trial is recruiting 28 individuals with liver condition in the age range between 50 and 75. Notably, participants need to agree that they will not use warfarin or phenytoin (and similar vitamin K antagonist anticoagulants) from screening through 2 weeks after administration of study drug."
Answered by AI
Does this research endeavor accept patients below the age of 50?
"This trial is including individuals aged between 50 and 75 years."
Answered by AI
What risks do individuals face when undergoing this treatment?
"This treatment has been evaluated and given a score of 1 on the scale since it is currently in Phase 1, indicating that limited data exists to support its safety or efficacy."
Answered by AI
How many participants are currently being recruited for this investigation?
"Indeed, the information on clinicaltrials.gov states that this trial is still enrolling participants. The initial posting of this study was made on February 20th2023 and it has been refreshed as recently as May 19th2023. As such, 28 individuals are being recruited across 3 different medical centres."
Answered by AI
Is enrollment for this clinical trial open at present?
"The clinicaltrial.gov website shows that this research endeavor is actively seeking patients; first posted on February 20th, 2023 and last edited on May 19th, 2023."
Answered by AI
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