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Completed

NCT Number: NCT06340347

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

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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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange County Research Center, Lake Forest, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osivelotor

Drug

a single dose of osivelotor administered by mouth under fasted conditions

Other Names:

PF-07940367

Primary outcomes

  1. 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

    Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose

  2. Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor

    Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose

  3. Maximum observed whole blood and plasma concentration (Cmax) of osivelotor

    Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs)

    Time frame: From baseline up to 56 days after osivelotor dose

  2. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: From baseline up to 84 days after osivelotor dose

  3. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

    Time frame: From baseline up to 84 days after osivelotor dose

  4. Number of Participants With Clinically Significant With Clinically Significant Vital Signs

    Time frame: From baseline up to 84 days after osivelotor dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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