Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756531
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2021-02-11
Brief Title:
STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 RANDOMIZED DOUBLE-BLIND SPONSOR-OPEN PLACEBO CONTROLLED SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY TOLERABILITY AND PHARMACOKINETICS OF PF 07321332 IN HEALTHY ADULT PARTICIPANTS
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:
A Phase 1 double blind sponsor open single and multiple ascending dose study to evaluate safety tolerability and pharmacokinetics of PF-07321332 in healthy participants
Detailed Description:
Combined 5-part study Part-1 Single Ascending dose Part-2 Multiple Ascending Dose Part-3 Relative bioavailability and food effect Part-4 Metabolism and Excretion Part-5 Supra-therapeutic Exposure Part-12 and 5 are double blind sponsor open and Part-3 and 4 are open label study
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 |
|---|---|---|---|
| 2020-006073-30 | EUDRACT_NUMBER | None | None |