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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43
Awards & highlights
Study Summary
This trial will assess the safety and tolerability of AZD0780 in two parts. Part A will study the effects of a single dose of AZD0780 in healthy subjects with or without elevated LDL-C levels. Part B will study the effects of multiple doses of AZD0780 in healthy subjects with or without elevated LDL-C levels.
Who is the study for?
This trial is for healthy adults aged 18-55 with suitable veins for cannulation, a BMI of 18-35 kg/m2, and weighing between 50-120 kg. Japanese or Chinese heritage individuals are eligible based on specific criteria. Women must not be pregnant or able to become pregnant. Participants should have LDL-C levels within certain ranges and cannot have had significant medical procedures, drug abuse history, excessive alcohol consumption, recent vaccinations, or any condition affecting drug absorption.Check my eligibility
What is being tested?
The study tests the safety and effects of AZD0780 on cholesterol levels in healthy subjects with/without high LDL-C. It involves single/multiple doses compared against Rosuvastatin (a known cholesterol-lowering medication) and Placebo over two parts involving up to 172 participants.See study design
What are the potential side effects?
Potential side effects may include reactions typical of clinical trials such as discomfort at the injection site, nausea, headaches or dizziness; however specific side effects will be monitored given this is an assessment of safety and tolerability.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects with Adverse Events
Secondary outcome measures
Amount of unchanged drug excreted into urine from zero to the last quantifiable concentration by interval and cumulatively (Ae[0-last])
Area under plasma concentration time curve from zero to infinity (AUCinf)
Area under plasma concentration time curve from zero to t hours post-dose (AUC[0-t])
+6 moreTrial Design
14Treatment groups
Active Control
Group I: Cohort 13: Part B - placebo tablet/rosuvastatin dose 12Active Control2 Interventions
A total of 20 subjects will receive single dose of placebo and rosuvastatin.
Group II: Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12Active Control2 Interventions
A total of 20 subjects will receive single dose of AZD0780 and rosuvastatin.
Group III: Cohort 5: Part A1 - AZD0780 dose 5/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Group IV: Cohort 10: Part B - AZD0780 dose 10/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.
Group V: Cohort 4: Part A1 - AZD0780 dose 4/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Group VI: Cohort 6: Part B - AZD0780 dose 6/placebo tabletActive Control2 Interventions
A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
Group VII: Cohort 7: Part B - AZD0780 dose 7/placebo tabletActive Control2 Interventions
A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
Group VIII: Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12Active Control3 Interventions
A total of 20 subjects will receive AZD0780 in combination with rosuvastatin or 5 subjects will receive placebo in combination with rosuvastatin.
Group IX: Cohort 2: Part A1 - AZD0780 dose 2/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Group X: Cohort 3: Part A1 - AZD0780 dose 3/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Group XI: Cohort 9: Part B - AZD0780 dose 9/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.
Group XII: Cohort 11: Part A2 - AZD0780 dose 11/placebo tabletActive Control2 Interventions
A total of 5 subjects will receive single ascending doses of AZD0780 and placebo.
Group XIII: Cohort 8: Part B - AZD0780 dose 8/placebo tabletActive Control2 Interventions
A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
Group XIV: Cohort 1: Part A1 - AZD0780 dose 1/placebo tabletActive Control2 Interventions
A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,613,188 Total Patients Enrolled
9 Trials studying High Cholesterol
11,022 Patients Enrolled for High Cholesterol
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,016 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of drinking too much alcohol.I received my first COVID-19 vaccine within the last 30 days.I received my second COVID-19 vaccine shot within the last 10 days.You have any important abnormal test results for blood, urine, or other lab tests.I haven't taken any new drugs within the last 30 days or 5 half-lives before starting this study.You have a heart condition that affects the electrical activity of your heart as shown on a resting electrocardiogram (ECG).I am between 18 and 55 years old, healthy, and my veins can be used for repeated needle insertions.You have tested positive for hepatitis B, hepatitis C, or HIV.I have smoked or used nicotine products in the last 3 months.You have a history of severe allergies or hypersensitivity to drugs similar to AZD0780.I have tested positive for COVID-19 with a PCR test during screening.You have tested positive for illegal drugs, nicotine, or alcohol when you were screened for the study.I can communicate clearly with my doctor.I haven't taken any medication, including over-the-counter and herbal remedies, for the last 2 weeks.I have not taken AZD0780 in the last 60 days.Criterion: If you are Japanese or Chinese, you have specific requirements for your family background and birthplace. Additionally, your cholesterol and triglyceride levels must meet certain standards for different parts of the study.I haven't donated blood or plasma in the last month.Your vital signs, like heart rate and blood pressure, are not normal after resting for 10 minutes.I haven't taken drugs like St John's Wort in the last 3 weeks.You have a history of using drugs in a harmful way.You consume a lot of drinks or food with caffeine.I haven't had any major illnesses or surgeries in the last 4 weeks.I have a history of a significant health condition.You follow a vegan diet or have specific dietary restrictions for medical reasons.I have no conditions that affect how my body handles medicine.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 13: Part B - placebo tablet/rosuvastatin dose 12
- Group 2: Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12
- Group 3: Cohort 5: Part A1 - AZD0780 dose 5/placebo tablet
- Group 4: Cohort 10: Part B - AZD0780 dose 10/placebo tablet
- Group 5: Cohort 4: Part A1 - AZD0780 dose 4/placebo tablet
- Group 6: Cohort 6: Part B - AZD0780 dose 6/placebo tablet
- Group 7: Cohort 7: Part B - AZD0780 dose 7/placebo tablet
- Group 8: Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12
- Group 9: Cohort 2: Part A1 - AZD0780 dose 2/placebo tablet
- Group 10: Cohort 3: Part A1 - AZD0780 dose 3/placebo tablet
- Group 11: Cohort 9: Part B - AZD0780 dose 9/placebo tablet
- Group 12: Cohort 11: Part A2 - AZD0780 dose 11/placebo tablet
- Group 13: Cohort 8: Part B - AZD0780 dose 8/placebo tablet
- Group 14: Cohort 1: Part A1 - AZD0780 dose 1/placebo tablet
Awards:
This trial has 0 awards, including: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.
What qualifications must one possess in order to participate in this research?
"This study is actively searching for 132 individuals who have dyslipidemias and fall into the age bracket of 18 to 50 years old."
Answered by AI
Is enrollment for this research still available to the public?
"Affirmative. Clinicaltrials.gov data indicates that this clinical trial, which was originally posted on May 18th 2022, is actively searching for participants. There is a need to recruit 132 patients from 2 different sites in total."
Answered by AI
Has this medication been sanctioned by the FDA for therapeutic purposes?
"Our analysis of the data puts this treatment's safety rating at a 1, as it is currently in Phase 1 trials. This indicates limited evidence for its efficacy and lack of robust testing regarding side effects."
Answered by AI
Are individuals aged 50 or above considered eligible for this clinical trial?
"Eligible candidates for this medical study must be 18 to 50 years of age. If you are younger or older than the prescribed range, there may still be options; 6 studies target minors and 54 trials focus on those above 65."
Answered by AI
To what extent is this clinical trial recruiting participants?
"Yes, according to clinicaltrials.gov the study is still open for recruitment, having been initially posted on May 18th 2022 and last edited on November 9th 2022. The medical team requires 132 participants from 2 different trial sites."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
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