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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-09-18

Brief Summary

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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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Detailed Description

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Conditions

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Liver Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

An open label, single dose, parallel cohort study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Osivelotor

Intervention Type DRUG

a single dose of osivelotor administered by mouth under fasted conditions

Other Names:

PF-07940367

Group 2

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

Group Type EXPERIMENTAL

Osivelotor

Intervention Type DRUG

a single dose of osivelotor administered by mouth under fasted conditions

Other Names:

PF-07940367

Interventions

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Osivelotor

a single dose of osivelotor administered by mouth under fasted conditions

Other Names:

PF-07940367

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No