Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340347
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-25
Brief Title:
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor PF-07940367 in People With Loss of Liver Function
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL SINGLE-DOSE NON-RANDOMIZED PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS SAFETY AND TOLERABILITY OF OSIVELOTOR PF-07940367 IN ADULT PARTICIPANTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT
Status:
RECRUITING
Status Verified Date:
2024-10
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 Osivelotor is processed in people with loss of liver function
This study is seeking participants that are
stable loss of liver function with mild or moderate severity
none of underlying conditions possibly affecting the study medicine being absorbed by the body
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body Participants will also have to undergo physical examination and other tests This will help to understand if Osivelotor is safe
Participants will take part in the study for a maximum of 112 days During this time participants will have to stay onsite for 5 days There will be 5 study visits at the study clinic
This study is seeking participants that are
stable loss of liver function with mild or moderate severity
none of underlying conditions possibly affecting the study medicine being absorbed by the body
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body Participants will also have to undergo physical examination and other tests This will help to understand if Osivelotor is safe
Participants will take part in the study for a maximum of 112 days During this time participants will have to stay onsite for 5 days There will be 5 study visits at the study clinic
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GBT601 | OTHER | Alias Study Number | None |