A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		No renal impairment
  • Drug: PF-07817883
    Experimental
Experimental
Cohort 2 		Severe renal impairment
  • Drug: PF-07817883
    Experimental
Experimental
Cohort 3 		Moderate renal impairment
  • Drug: PF-07817883
    Experimental

Recruiting Locations

Clinical Pharmacology of Miami
Miami, Florida 33014-3616

Genesis Clinical Research, LLC
Tampa, Florida 33603

Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota 55114

More Details

NCT ID
NCT06586216
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com