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

Last updated: January 8, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Osivelotor

Clinical Study ID

NCT06340347
C5351010
GBT601
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greaterthan 50 kg (greater than 110 lb)

  • Stable hepatic impairment that meets the criteria for Class A or B of the Child Pughclassification with no clinically significant change in disease status within the 28days prior to the screening visit

  • Stable concomitant medications for the management of individual participants'medical history

Exclusion

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 hepatocellularprocess 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 activeStage 2 encephalopathy is allowed if, in the opinion of the investigator, theparticipant is able to provide informed consent.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Osivelotor
Phase: 1
Study Start date:
April 30, 2024
Estimated Completion Date:
September 18, 2024

Connect with a study center

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Elixia EPCT

    Tampa, Florida 33618
    United States

    Active - Recruiting

  • Genesis Clinical Research, LLC

    Tampa, Florida 33603
    United States

    Site Not Available

  • Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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