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Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125 — ADME  

Healthy Volunteer Clinical Trial

Official title:
An Open-Label,2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structure for [14C]-AQX-1125 in Healthy Subjects

Clinical Trial Summary

This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.

Clinical Trial Description

This is a single-centre, open-label, non-randomised, 2-part, sequential dose study in healthy male and female subjects. It is planned to enrol a single cohort of 8 healthy subjects (4 male and 4 female) who will participate in Part 1 and Part 2 of the study.

In Part 1, each subject will receive a single oral dose of AQX-1125 followed by an IV microtracer dose of carbon-14-AQX-1125 ([14C]-AQX-1125). In Part 2, each subject will receive a single oral dose of [14C]-AQX-1125. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03185195
Study type Interventional
Source Aquinox Pharmaceuticals (Canada) Inc.
Contact
Status Completed
Phase Phase 1
Start date November 22, 2016
Completion date January 4, 2017
View Details
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