COVID-19
Conditions
Keywords
Hepatic Impairment, COVID-19
Brief summary
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. This study is seeking participants who: * are male or female of 18- 75 years of age * either have different amounts of damage to liver function or for one of the groups, no damage * willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4. If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
Interventions
DRUGPF-07817883
Experimental
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification; * (all Cohorts): BMI of 17.5 to 38.0 kg/m2
Exclusion criteria
* Any condition possibly affecting drug absorption Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07817883 | Day 1 to Day 6 | Plasma PF-07817883 PK parameters |
| Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf) | Day 1 to Day 6 | Plasma PF-07817883 PK parameter |
| Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | Day 1 to Day 6 | (Optional) Plasma PF-07817883 parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Clinically Significant Abnormal Vital Signs | Day 1 to Day 6 | Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate |
| Number of Participants with Non-Serious Adverse Events | Screening to Day 35 | Safety Parameters |
| Number of Participants with Serious Adverse Events | Screening to Day 35 | Safety Parameters |
| Number of Participants with Clinically Significant Abnormal Laboratory Values | Baseline to Day 6 | Blood hematology and Chemistry and Urinalysis |
| Number of Participants with Treatment Emergent Adverse Events | Day 1 to Day 35 | Safety Parameters |
| Number of Participants with Clinically Significant ECG Abnormalities | Day 1 to Day 6 | ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate |
Countries
United States
Outcome results
None listed