Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT03775668
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2018-12-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers
Sponsor:
Allecra
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Single-Dose Study to Assess the Mass Balance, Pharmacokinetics and Metabolism of Intravenously Administered 14C-AAI101 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2018-12
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 an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in the United States (USA). This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered 14C-AAI101.
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?: