Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT07080658
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2024-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
[14C] Study to Investigate the Mass Balance and Biotransformation of WPV01 in Healthy Adult Chinese Male Participants
Sponsor:
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study to Investigate The Mass Balance and Biotransformation of WPV01 in Healthy Adult Chinese Male Participants
Status:
COMPLETED
Status Verified Date:
2025-04
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 is a single-center, non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of WPV01 in healthy adult chinese male participants following a single oral administration of \[14C\] WPV01.
Detailed Description:
This trial is planned to enroll 6-8 healthy Chinese male subjects. Each subject is administered a single oral dose containing 600 mg/approximately 100 µCi \[14C\]WPV01 suspension on the first day of the trial in fasting condition.
Whole blood, plasma, urine and fecal samples are collected at defined time points/periods during the test. The whole blood/plasma partition ratio, pharmacokinetic parameters of total radioactivity in plasma, recovery and excretion pathway data of \[14C\]WPV01 are calculated by measuring the total radioactivity. The major metabolic elimination pathways and characterization of WPV01 in the human body, as well as circulating metabolites that are close to or above 10% of total plasma radioactivity exposure, are obaitned from structural characterization of plasma, urine and fecal radio-metabolite profiles and major metabolites.
All excreted urine and fecal samples are collected at specified time intervals from 0 to 336h post-dose and and blood samples are collected at specified time points from 0 to 144h post-dose.
Whole blood, plasma, urine and fecal samples are collected at defined time points/periods during the test. The whole blood/plasma partition ratio, pharmacokinetic parameters of total radioactivity in plasma, recovery and excretion pathway data of \[14C\]WPV01 are calculated by measuring the total radioactivity. The major metabolic elimination pathways and characterization of WPV01 in the human body, as well as circulating metabolites that are close to or above 10% of total plasma radioactivity exposure, are obaitned from structural characterization of plasma, urine and fecal radio-metabolite profiles and major metabolites.
All excreted urine and fecal samples are collected at specified time intervals from 0 to 336h post-dose and and blood samples are collected at specified time points from 0 to 144h post-dose.
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?:
False
Is an FDA AA801 Violation?: