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

Launched by PFIZER · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called PF-07817883 to understand how it is processed in the body of adults with different levels of kidney function. The aim is to learn how safe this medicine is for people who have moderate or severe kidney impairment compared to those with healthy kidneys. Participants will be grouped based on the level of kidney function they have, and all participants must be between 18 and 90 years old and willing to stay at the clinic for 5 nights and 6 days.

If you decide to join the study, you will first go through some tests to make sure you qualify. If you are eligible, you will receive a single dose of the study medicine on the first day, and blood samples will be taken to see how your body processes the medicine. After being monitored for a few days at the clinic, you will go home, but there will be a follow-up call or visit about a month later to check on your health. The entire study will last between 5 to 10 weeks. It’s important to know that this study cannot include individuals with certain health conditions, such as recent COVID-19 infection or a history of specific viral infections.

Gender

ALL

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