NCT05884554

A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. This study is seeking participants who: * are male or female of 18- 75 years of age * either have different amounts of damage to liver function or for one of the groups, no damage * willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4. If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing. 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: 2023-06-15
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2023-06-01
• Last updated: 2024-09-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study