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Osivelotor for Liver Disease
Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to investigate how Osivelotor is processed in individuals with liver dysfunction. They are looking for participants with stable mild to moderate liver dysfunction and no other conditions that could affect how the medication works
Who is the study for?
This study is for individuals with stable liver disease of mild or moderate severity, who have a BMI between 16 to 40 kg/m2 and weigh over 50 kg. They should not have had significant changes in their condition within the last month and must be on stable medications for any other health issues.
What is being tested?
The trial is testing how Osivelotor, a medication taken by mouth, is processed by people with impaired liver function. Participants will take one dose before breakfast on the first day and undergo blood tests, physical exams, and other assessments over a maximum of 112 days with five clinic visits.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored through physical exams and tests to ensure Osivelotor's safety. Side effects could relate to how the drug affects liver processing.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have liver cancer, kidney issues related to liver disease, or a short expected lifespan.
Select...
I have liver problems confirmed by tests or a doctor's exam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
Group II: Group 1Experimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,213 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,021 Total Patients Enrolled