← Back to Search

Other

AZD0780 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

Participant must be 18 to 85 years of age, inclusive at screening

For male participants: Males must be surgically sterile or using, in conjunction with their female partner, a highly effective method of contraception for the duration of the study until 3 months after discharge to prevent pregnancy in a partner.

Must not have

For participants with hepatic impairment: Use of moderate/strong inhibitors or inducers of CYP3A4/5.

For participants with hepatic impairment: Participant has evidence of hepatorenal syndrome or creatinine clearance < 60 mL/minute as calculated using the Cockcroft-Gault equation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 11

Awards & highlights

Summary

"This trial will test how a new drug, AZD0780, is processed in the body, as well as how safe and well-tolerated it is when given to people with liver problems compared

Who is the study for?

This trial is for adults with moderate or possibly mild liver disease. Participants must be matched in health status to a control group without liver issues. Specific details on inclusion and exclusion criteria are not provided, but typically these would cover factors like age, severity of liver disease, other medical conditions, and medications that might interfere.

What is being tested?

The study is testing the effects of a single oral dose of AZD0780 on people with different levels of liver health. It aims to understand how the drug moves through the body (pharmacokinetics), its safety profile, and how well participants tolerate it compared to healthy individuals.

What are the potential side effects?

While specific side effects are not listed for AZD0780, common ones related to drugs affecting the liver may include nausea, vomiting, abdominal pain, fatigue, itching skin or jaundice. The trial will monitor all adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old.

Select...

I am a male and either surgically sterile or using effective birth control.

Select...

I have documents proving my liver condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking strong medication that affects liver enzyme activity.

Select...

I have liver problems and my kidneys are not working well.

Select...

I have liver issues and a higher risk of bleeding.

Select...

I have liver cancer or acute liver disease due to infection or drug toxicity.

Select...

My liver issues are not caused by liver disease.

Select...

I do not have severe liver-related brain issues.

Select...

I do not have any significant health issues apart from my current condition.

Select...

I have a functioning organ transplant or expect to get one soon.

Select...

I started new medication for liver-related brain issues in the last 3 months.

Select...

I am taking medication that affects kidney function due to liver issues.

Select...

I can't stop taking certain medications for my liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUCinf

AUClast

Cmax

Secondary study objectives

Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings

Number of participants with abnormal laboratory tests results

Number of participants with adverse events (AEs)

+8 more

Other study objectives

Multi-omics Analysis

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3 (optional)Experimental Treatment1 Intervention

Subjects with Mild Impairment will receive a single oral dose of AZD0780 under fasted conditions.

Group II: Group 2Experimental Treatment1 Intervention

Healthy participants will receive a single oral dose of AZD0780 under fasted conditions.

Group III: Group 1Experimental Treatment1 Intervention

Subjects with Moderate Impairment will receive a single oral dose of AZD0780 under fasted conditions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD0780

2023

Completed Phase 1

~200

0 / 14Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,352 Previous Clinical Trials

288,646,777 Total Patients Enrolled

~21 spots leftby Nov 2024

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.