NCT04434326

The Absorption, Metabolism and Excretion of [14C]CM082 in Human

A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]CM082 After a Single Oral 200mg/100µCi Dose in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: AnewPharma · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] CM082 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study

Detailed description

Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (100 μCi) of \[14C\]CM082 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	[14]CM082 suspension	Before administration, the solid powder for administration was placed at room temperature. 40 ml drinking water was added into the drug container to prepare the suspension for the subjects to take. After that, 200 ml drinking water was used to repeatedly rinse the drug container for many times, and the subjects continued to take the lotion. Take care not to spill the liquid out of the bottle when shaking

Timeline

• Start date: 2021-07-05
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2020-06-16
• Last updated: 2022-11-14

Locations

1 site across 1 country: China