Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05119790
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2021-08-27
Brief Title:
A Study of Mass Balance Pharmacokinetics Metabolite Profile and Metabolite Identification of BIIB122DNL151 in Healthy Male Subjects
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
An Open Label Phase 1 Study of Mass Balance Pharmacokinetics Metabolite Profile and Metabolite Identification of a Single Oral Dose of 14C-BIIB122 14C DNL151 in Healthy Male Subjects
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:
This is a single-center non-randomized open-label Phase 1 study to determine the absorption metabolism and excretion AME of BIIB122 DNL151 following administration of a single oral dose of 14C BIIB122 14C DNL151 following a fast The mass balance excretion and PK of BIIB122 DNL151 will be used to evaluate AME
Detailed Description:
This clinical trial information was submitted voluntarily under the applicable law and therefore certain submission deadlines may not apply That is clinical trial information for this applicable clinical trial was submitted under section 402j4A of the Public Health Service Act and 42 CFR 1160 and is not subject to the deadlines established by sections 402j2 and 3 of the Public Health Service Act or 42 CFR 1124 and 1144
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