Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT04638803
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2020-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Sponsor:
Praxis Bioresearch, LLC
Organization:
Study Overview
Official Title:
A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-11
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 goal of the present study is to confirm in humans the in-vivo bioconversion of a Prodrug (PRX-P4-003) to (-)-fencamfamine (FCF) the active moiety when orally administered as a single microdose. A second component of the study will evaluate effect of food on pharmacokinetics of PRX-P4-003.
Detailed Description:
A crossover study comparing blood concentrations after oral administration of microdoses of (-)-fencamfamine (FCF; 40 µg) or its prodrug form (PRX-P4-003; 100 µg)) in the fasted state will be carried out in 4 healthy male volunteers (Study A). This will be followed by determination of blood concentrations of (-)-fencamfamine in a separate cohort of 4 volunteers following oral administration of a microdose of PRX-P4-003 (100 µg) in a fed state (Study B).
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44116764 | OTHER_GRANT | NIMH | View |