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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Drug: Osivelotor

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
  • Florida
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants with moderate 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
Experimental: Group 2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): September 18, 2024
• Study Completion (Actual): September 18, 2024

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: C5351010; GBT601 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No