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Group 2 for Liver Disease

Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 56 days after osivelotor dose
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 56 days after osivelotor dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 56 days after osivelotor dose 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 the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
Secondary outcome measures
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of Participants With Clinically Significant With Clinically Significant Vital Signs
+1 more

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
4,575 Previous Clinical Trials
10,923,085 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,482 Previous Clinical Trials
8,099,347 Total Patients Enrolled

Frequently Asked Questions

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

Has Group 2 received FDA authorization?

"According to our assessment at Power, Group 2 safety is rated as 1 due to the Phase 1 trial status indicating limited evidence supporting both safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
2024. "A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06340347.
All > Liver Disease
~11 spots leftby Sep 2025
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