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AZD2693 for Liver Disease

Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights

Study Summary

This trial tests if a single dose of a drug safely helps people with liver issues.

Who is the study for?
This trial is for adults with stable liver disease and healthy individuals without significant medical issues. Participants must weigh at least 50 kg, have a BMI of 18-40, and normal kidney function. Those with thyroid diseases, unstable health conditions, HIV, or recent major surgery cannot join.Check my eligibility
What is being tested?
The study tests the effects of a single subcutaneous dose of AZD2693 on people with different levels of liver health. It aims to understand how liver impairment affects the drug's behavior in the body as well as its safety and tolerability.See study design
What are the potential side effects?
While specific side effects are not listed here, common reactions to new drugs can include irritation at injection site, nausea, headaches, allergic reactions or more serious complications depending on individual responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

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 Cmax
Secondary outcome measures
PK Parameters Vz/F
PK parameters Ae
PK parameters CL/F
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups
Group II: Group 3Experimental Treatment1 Intervention
Participants with severe hepatic impairment (CP Class C, score of 10 to 15)
Group III: Group 2Experimental Treatment1 Intervention
Participants with moderate hepatic impairment (CP Class B, score of 7 to 9)
Group IV: Group 1Experimental Treatment1 Intervention
Participants with mild hepatic impairment (CP Class A, score of 5 or 6)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2693
2020
Completed Phase 1
~200

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,274 Previous Clinical Trials
288,613,385 Total Patients Enrolled

Media Library

AZD2693 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05919069 — Phase 1
Liver Disease Research Study Groups: Group 1, Group 2, Group 3, Group 4
Liver Disease Clinical Trial 2023: AZD2693 Highlights & Side Effects. Trial Name: NCT05919069 — Phase 1
AZD2693 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919069 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment open at the moment?

"According to clinicaltrials.gov, this research trial is no longer seeking participants; the study was initially posted on June 19th 2023 and updated for the last time on June 16th 2023. Fortunately, there are currently 278 other studies actively enrolling volunteers."

Answered by AI

To what extent does Group 1 pose a threat to the well-being of those it affects?

"On account of limited evidence for efficacy and safety, Group 1 was assigned a score of 1. This is congruent with the Phase 1 designation given to this trial."

Answered by AI

Does this research project accept participants under the age of twenty-five?

"This trial is open to adult patients aged 18 and older, up to the age of 75."

Answered by AI

Are there any prerequisites for participation in this research project?

"Eligible candidates for this experiment are those aged 18-75 who have been diagnosed with a liver condition. 36 participants will be accepted in total."

Answered by AI

What ambitions does this research seek to accomplish?

"As relayed by the trial's sponsor, AstraZeneca, the primary efficacy measure is PK parameters AUClast over an 85 day period. Additionally, secondary objectives such as tlast (time of last measurable concentration), t1/2λz (apparent terminal elimination half-life) and CL/F (apparent clearance) will be monitored."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693
2023. "A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05919069.
~10 spots leftby Oct 2024
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