NCT02298920

AZD0914 Phase 1 ADME Study in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Entasis Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AZD0914	Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-11-24
• Last updated: 2015-06-03

Locations

2 sites across 1 country: United States