Official Title
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
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 12participants may be selected. If participants agree to take part in the study, it maytake up to 4 weeks to complete all the tests to confirm if they are fit to be in thestudy. If they seem to be fit for the study, participants will be admitted to a clinicresearch unit (CRU) at least 8 hours before dosing.On Day 1, participants will receive a single amount of study medicine (Day 1). A seriesof blood samples will be collected before and after giving medicines. Participants willbe 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 minimumof 5 weeks and a maximum of 10 weeks.

Detailed Description

Not Provided

Completed
COVID-19

Drug: PF-07817883

Experimental

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
United States
Locations

Clinical Pharmacology of Miami
Miami 4164138, Florida 4155751, United States

Genesis Clinical Research, LLC
Tampa 4174757, Florida 4155751, United States

Prism Research LLC dba Nucleus Network
Saint Paul 5045360, Minnesota 5037779, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
Renal Impairment
Covid-19
MeSH Terms
COVID-19
Renal Insufficiency