COVID-19
Conditions
Keywords
Renal Impairment, COVID-19
Brief summary
The purpose of the study is to learn about: * how PF-07817883 is processed in the body of adult participants. * the safety of PF-07817883. These participants will have different levels of kidney function loss: * moderate * severe * none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups. This study is seeking for participants who: * are male or female of 18 to 90 years of age. * have different levels of damage to kidney function or for one of the groups, no damage * are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days. About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing. On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. 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 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants aged 18 (or the minimum age of consent in accordance with local regulations) to 90 years of age at screening. * BMI of ≥16 kg/m2 and a total body weight \>45 kg (99 lbs). * Stable renal function, defined as the eGFR values obtained at the two screening visits should not be more than 25% different.
Exclusion criteria
* Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1. * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccination is allowed. * Renal transplant recipients. * Any condition possibly affecting drug absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07817883 | Day 1 to Day 5 | Plasma PF-07817883 PK parameters |
| Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf) | Day 1 to Day 5 | Plasma PF-07817883 PK parameters |
| Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | Day 1 to Day 5 | Plasma PF-07817883 parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Clinically Significant Abnormal Vital Signs | Day 1 to Day 5 | — |
| Number of participants with Non-Serious Adverse Events (NSAE) | Screening to Day 35 | Safety Parameter |
| 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 5 | — |
| Number of participants with Treatment Emergent Adverse Events | Day 1 to Day 35 | Safety Parameter |
| Number of participants with Clinically Significant ECG Abnormalities | Day 1 to Day 5 | — |
Countries
United States
Outcome results
None listed