Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-02 @ 3:59 PM
Study NCT ID:
NCT02298920
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD0914 Phase 1 ADME Study in Healthy Volunteers
Sponsor:
Entasis Therapeutics
Organization:
Study Overview
Official Title:
A Phase I, Open-Label Study to Assess the Absorption, Metabolism, Excretion, Safety and Tolerability of a Single Oral Dose of Radiolabeled [14C]-AZD0914 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2015-06
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 study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.
Detailed Description:
This is an open-label, single dose study in 6 healthy male subjects aged 18 to 55 years. Each subject will be admitted to the clinical pharmacology unit on the day prior to dosing Check in (Day -1) and will remain in the clinical pharmacology unit until up to at least target Day 8 (168 hours post-dose).
All subjects will receive 3000 mg AZD0914 incorporating 18.5 MBq (500 Ci) of \[14C\] administered as a single oral dose following at least an 8 hour fast from food. Subjects can have water. For specific food and water restrictions.
This study will investigate the metabolic fate and routes of excretion of AZD0914.
All subjects will receive 3000 mg AZD0914 incorporating 18.5 MBq (500 Ci) of \[14C\] administered as a single oral dose following at least an 8 hour fast from food. Subjects can have water. For specific food and water restrictions.
This study will investigate the metabolic fate and routes of excretion of AZD0914.
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?: