Liver Diseases
Conditions
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.
Interventions
DRUGOsivelotor
a single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
An open label, single dose, parallel cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | From baseline up to 56 days after osivelotor dose |
| Number of Participants With Clinically Significant With Clinically Significant Vital Signs | From baseline up to 84 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 |
Countries
United States
Outcome results
None listed