Clinical trial NCT06340347: A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-04-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open label, single dose, parallel cohort study
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 0 hours (pre-dose) to 84 days post-osivelotor dose
measure: Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
timeFrame: 0 hours (pre-dose) to 84 days post-osivelotor dose
measure: Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
timeFrame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: From baseline up to 56 days after osivelotor dose
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: From baseline up to 84 days after osivelotor dose
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: From baseline up to 84 days after osivelotor dose
measure: Number of Participants With Clinically Significant With Clinically Significant Vital Signs
timeFrame: From baseline up to 84 days after osivelotor dose
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Philadelphia
country: United States
facility: Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: