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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340347
• Other study ID #: C5351010
• Secondary ID: GBT601
• Status: Recruiting
• Phase: Phase 1
• Start date: April 30, 2024
• Est. completion date: September 9, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 9, 2025
• Est. primary completion date: September 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Orange County Research Center	Lake Forest	California
United States	Elixia EPCT	Tampa	Florida
United States	Genesis Clinical Research, LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum observed whole blood and plasma concentration (Cmax) of osivelotor		0 hours (pre-dose) to 84 days post-osivelotor dose
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs)		From baseline up to 56 days after osivelotor dose
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities		From baseline up to 84 days after osivelotor dose
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings		From baseline up to 84 days after osivelotor dose
Secondary	Number of Participants With Clinically Significant With Clinically Significant Vital Signs		From baseline up to 84 days after osivelotor dose

External Links

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