Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT07080658
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.
Study:
NCT07080658
Study Brief:
Protocol Section:
NCT07080658