Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05431153
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2022-06-09
Brief Title:
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 RANDOMIZED OPEN-LABEL 4-PERIOD 5-TREATMENT 6-SEQUENCE CROSSOVER SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE BIOAVAILABILITY OF PF-07104091
Status:
COMPLETED
Status Verified Date:
2023-10
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:
This is a single dose crossover pharmacokinetic pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it study in healthy participants The study consists of 5 treatments and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation andor whether the dose is to be given under fasted or fed conditions Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091
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