Study identifier:D4930C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy
Phase 1
Yes
AZD0914
Male
6
Interventional
18 Years - 55 Years
Allocation: Non-randomized
Endpoint Classification: N/A
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jun 2015 by Entasis Therapeutics
Entasis Therapeutics
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This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.
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.
Location
Location
Madison, WI, United States, 53704
Location
Madison, WI, United States
Arms | Assigned Interventions |
---|---|
Experimental: Single Group Open Label ADME Study | Drug: AZD0914 Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers. |
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