Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037031
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-09-07
Brief Title:
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL NON-RANDOMIZED SINGLE-DOSE PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS SAFETY AND TOLERABILITY OF PF-07923568 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to understand how the loss of kidney function affects study medicine PF-07923568 in the body People with some level of loss of kidney function may process PF-07923568 differently from healthy people PF-07923568 is developed as a possible treatment for respiratory syncytial virus RSV infection RSV is a common virus that affects the lungs and usually causes mild cold-like symptoms RSV can cause severe lung infections in infants elderly and adults with other serious medical conditions
This study is seeking participants who
Have less than 25 difference in kidney function between 2 screening visits
Meet the eGFR criteria for being assigned to groups eGFR tells how well the kidney is filtering
Are not on hemodialysis Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to
Participants will take the study medicine as capsules by mouth once at the study clinic The participants will stay at the study clinic for about 5 days During that time the study team will monitor the participants The study team will take some blood samples to test the level of PF-07923568 This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568
This study is seeking participants who
Have less than 25 difference in kidney function between 2 screening visits
Meet the eGFR criteria for being assigned to groups eGFR tells how well the kidney is filtering
Are not on hemodialysis Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to
Participants will take the study medicine as capsules by mouth once at the study clinic The participants will stay at the study clinic for about 5 days During that time the study team will monitor the participants The study team will take some blood samples to test the level of PF-07923568 This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None