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Balcinrenone for Liver Disease

Phase 1
Recruiting
Led By Eric J Lawitz, M.D.
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 79 years of age, inclusive, at the time of signing the informed consent.
Be older than 18 years old
Must not have
Participant has eGFR < 60 mL/minute/1.73 m2, history of severe allergy/hypersensitivity, history of long QT syndrome or any clinically significant abnormalities on 12-lead ECG, signs or confirmation of COVID-19 infection, positive test for HIV, positive results for hepatitis B or hepatitis C, history or presence of clinically significant thyroid disease, history or presence of clinically significant or unstable medical or psychiatric condition, participant is mentally or legally incapacitated or has significant emotional problems, history of any major surgical procedure within 30 days prior to study intervention, any clinically or surgically significant condition that may affect balcinrenone absorption and/or excretion, use of prohibited medication within 2 weeks prior to study intervention, unable to refrain from specific medications for a specified period, received another new chemical entity within a defined timeframe, previous enrolment in the present study, participant smokes more than 10 cigarettes per day or equivalent and is unable to comply with nicotine restrictions, positive screen for drugs of abuse and/or alcohol test, receipt of blood products within specified timeframes, involvement of AstraZeneca or clinical unit employee or their close relatives, vulnerable participants, judgment by the investigator that the participant should not participate in the study, participants with hepatic impairment meeting specific criteria, participants with normal hepatic function meeting specific criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (day -28 to day -2) to day 10
Awards & highlights

Summary

This trial will look at how a single dose of balcinrenone is processed by the body, as well as its safety and how well it is tolerated, in patients with liver problems compared to a

Who is the study for?
This trial is for adults with mild to moderate liver disease, who will be compared to healthy adults. Participants must have stable liver impairment and not be taking certain medications that affect the liver.Check my eligibility
What is being tested?
The study tests how a single dose of Balcinrenone behaves in the body and its safety in those with varying degrees of liver health versus healthy individuals.See study design
What are the potential side effects?
Potential side effects of Balcinrenone may include changes in digestion, fatigue, headache, or alterations in blood pressure or heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 79 years old.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (day -28 to day -2) to day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (day -28 to day -2) to day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast)
Area under plasma concentration-time curve from zero to infinity (AUCinf)
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days])
Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings
Number of participants with abnormal laboratory tests results

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
Healthy participants will receive a single oral dose of balcinrenone under fasted conditions.
Group II: Group 2Experimental Treatment1 Intervention
Subjects with Moderate Impairment will receive a single oral dose of balcinrenone under fasted conditions.
Group III: Group 1Experimental Treatment1 Intervention
Subjects with Mild Impairment will receive a single oral dose of balcinrenone under fasted conditions.

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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
4,302 Previous Clinical Trials
288,624,571 Total Patients Enrolled
Eric J Lawitz, M.D.Principal InvestigatorServico Integrado de Tecnicas Endovasculares
Thomas C Marbury, M.D.Principal InvestigatorServico Integrado de Tecnicas Endovasculares
~14 spots leftby Nov 2024