Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-11 @ 6:55 AM
Study NCT ID:
NCT02598206
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2015-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect Study PF-04136309
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Open Label, Single Dose, 2-period Crossover Study To Evaluate Food Effect On The Pharmacokinetics Of Pf-04136309 In Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-04
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 evaluate the effect of food intake on PF-04136309 pharmacokinetics (PK) following a single dose at 1000 mg.
Detailed Description:
The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in the multiple dose setting in patients, will provide information to guide the dose administration in regards to food intake at relevant therapeutic dose levels for further studies in patients.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-003649-24 | EUDRACT_NUMBER | None | View |