NCT03185195

Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Aquinox Pharmaceuticals (Canada) Inc. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AQX-1125 Oral Tablet	Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.
DRUG	[14C]-AQX-1125 IV	Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.
DRUG	[14C]-AQX-1125 Oral Solution	Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

Timeline

• Start date: 2016-11-22
• Primary completion: 2017-01-04
• Completion: 2017-01-04
• First posted: 2017-06-14
• Last updated: 2017-06-14

Locations

1 site across 1 country: United Kingdom