Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392230
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-12
Brief Title:
A Study to Learn How the Medicine Called 14C PF-06821497 is Taken up Into and Removed From the Body
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL FIXED-SEQUENCE 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE ABSOLUTE BIOAVAILABILITY FRACTION ABSORBED AND PHARMACOKINETICS OF 14CPF-06821497 USING A 14C-MICROTRACER APPROACH
Status:
RECRUITING
Status Verified Date:
2024-09
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 learn how a certain amount of 14C PF-06821497 is taken up into the bloodstream and removed from the body
The study is seeking participants who are
Males aged 18 years or older
Are confirmed to be healthy after performing some medical and physical tests
Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared
The study consists of two parts In part one all participants will receive one full dose of 14CPF-06821497 by mouth Part two will begin at least 14 days after the dose in part one In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of 14CPF-06821497 by intravenous IV infusion IV infusion will be directly injected into the veins
To understand how the medicine is processed in the body samples of blood urine and feces will be collected after each dose is given This will help understand
How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV
How the body removes it from the bloodstream
Participants will take part in the study for about 11 weeks including the initial evaluation and follow-up periods
The study is seeking participants who are
Males aged 18 years or older
Are confirmed to be healthy after performing some medical and physical tests
Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared
The study consists of two parts In part one all participants will receive one full dose of 14CPF-06821497 by mouth Part two will begin at least 14 days after the dose in part one In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of 14CPF-06821497 by intravenous IV infusion IV infusion will be directly injected into the veins
To understand how the medicine is processed in the body samples of blood urine and feces will be collected after each dose is given This will help understand
How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV
How the body removes it from the bloodstream
Participants will take part in the study for about 11 weeks including the initial evaluation and follow-up periods
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508371-36-00 | REGISTRY | CTIS EU | None |