A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function

NCT06340347 — Phase 1, Completed, 8 participants, Pfizer

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NON-RANDOMIZED PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF OSIVELOTOR (PF-07940367) IN ADULT PARTICIPANTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT

Registry	NCT06340347
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	8 (Actual)
Sponsor	Pfizer (Industry)
Conditions	Liver Diseases
Interventions	Osivelotor (Drug)
Dates	start 2024-04-30, primary completion 2024-09-18, completion 2024-09-18, first posted 2024-04-01, last updated 2025-01-10
Locations	3 sites in United States

-Summary

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:

* stable loss of liver function with mild or moderate severity
* none of underlying conditions possibly affecting the study medicine being absorbed by the body

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Experimental	Drug: Osivelotor	Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
Group 2	Experimental	Drug: Osivelotor	Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.

Osivelotor (Drug): a single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367

+Outcome measures

Primary outcomes

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 [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 [0 hours (pre-dose) to 84 days post-osivelotor dose]
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor [0 hours (pre-dose) to 84 days post-osivelotor dose]

Secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs) [From baseline up to 56 days after osivelotor dose]
Number of Participants With Clinically Significant Laboratory Abnormalities [From baseline up to 84 days after osivelotor dose]
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings [From baseline up to 84 days after osivelotor dose]
Number of Participants With Clinically Significant With Clinically Significant Vital Signs [From baseline up to 84 days after osivelotor dose]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
* Stable hepatic impairment that meets the criteria for Class A or B of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
* Stable concomitant medications for the management of individual participants' medical history

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection, prior status portacaval shunt surgery);
* 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;
* Presence of clinically active Stage 3 or 4 hepatic encephalopathy. Clinically active Stage 2 encephalopathy is allowed if, in the opinion of the investigator, the participant is able to provide informed consent.

+Locations (3)

Facility	City	Country
Orange County Research Center	Lake Forest, California	United States
Genesis Clinical Research, LLC	Tampa, Florida	United States
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology	Philadelphia, Pennsylvania	United States

+Investigators

Pfizer CT.gov Call Center, Study director, Pfizer