A Phase 1 interventional study of Osivelotor in Liver Diseases, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.
This study is seeking participants that are:
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.
Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
Drug: Osivelotor
Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
Drug: Osivelotor
a single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367
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
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline up to 56 days after osivelotor dose
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant With Clinically Significant Vital Signs
Time frame: From baseline up to 84 days after osivelotor dose
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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