Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT03400995
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
Sponsor:
Shanghai Ark Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: