NCT06586216

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	PF-07817883	Experimental

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-02-13
• Completion: 2025-02-13
• First posted: 2024-09-19
• Last updated: 2025-02-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study