Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
Study NCT ID:
NCT05101369
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2021-10-06
Has Adverse Events:
False
Brief Title:
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
Sponsor:
Incyte Corporation
Organization:
Study Overview
Official Title:
An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
Status:
COMPLETED
Status Verified Date:
2025-08
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:
To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
Detailed Description:
The purpose of this study is to determine the absorption, metabolism, and excretion of a single oral dose of 400 mg (4x100 mg tablets) of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) \[14C\]-INCB086550 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces in healthy male participants .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|---|
| 2020-005879-12 | EUDRACT_NUMBER | None | View |