Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586216
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None