NCT03400995

A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529

An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-AK0529 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This phase I study is to assess the mass balance recovery after a single oral dose of \[14C\]-AK0529 in healthy male subjects.

Detailed description

This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of \[14C\]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AK0529	A solution containing 300 mg radiolabelled AK0529.

Timeline

• Start date: 2018-01-05
• Primary completion: 2018-02-27
• Completion: 2018-08-30
• First posted: 2018-01-17
• Last updated: 2018-09-11

Locations

1 site across 1 country: United Kingdom