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

NCT06340347 | Completed Phase 1 FDA Drug

• 2 other identifiers: C5351010GBT601
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (3)

• 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 (4)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.

Drug: Osivelotor

Group 2

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.

Drug: Osivelotor

Interventions

Osivelotor DRUG

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

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

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, single dose, parallel cohort study

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 30, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)