NCT05468645

In Vivo Mass Balance Study of [14C]Hemay005

In Vivo Mass Balance Study of a Single Oral Dose of [14C]Hemay005 in Healthy Chinese Male Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, single-dose, non-randomized, open-label study to evaluate the in vivo mass balance of \[14C\]Hemay005. Six healthy male subjects are planned to be enrolled.

Detailed description

The subjects are examined during the screening period (D-14 to D-2) and those who are qualified for the preliminary assessment are admitted to the clinical research center after qualification against the inclusion and exclusion criteria (D-2). After admission, they are trained on medication, urine and feces collection and other procedures to make sure that they can perform relevant operations according to the requirements of the protocol and corresponding operation manuals or procedures. Random urine and feces specimens (-24 h-0 h) are collected before dosing (D-1) and the subjects are deprived of food for at least 10 h and water for 1 h before dosing. On the morning of the first day of the study (D1), blood specimens are collected within 1 h before dosing, and the investigational product is taken orally on an empty stomach. The subjects are deprived of food for 4 h and water for 1 h after dosing. All urine and feces specimens excreted within the specified time intervals of 0-240 h and blood specimens sampled at specified time points within 0-168 h after dosing are collected. Phased testing is adopted in this study to determine whether specimen collection may be terminated in advance or the collection time needs to be prolonged based on the test results. If the specimen collection time exceeds that tentatively specified in the protocol, the collection should be extended at an interval of 24 h (urine, feces) or an integer multiple interval of 24 h (blood specimen) until the criteria for termination of specimen collection specified in the protocol are met. Meanwhile, the safety monitoring is continued until the completion date of the specimen collection.

Conditions

• Health Volunteer

Interventions

Type	Name	Description
DRUG	[14C]Hemay005	Name: \[14C\]Hemay005 Dose: 60 mg/100 µCi Storage: store at -10℃ to -30 °C, tightly closed and protected from light.

Timeline

• Start date: 2022-07-25
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-07-21
• Last updated: 2024-02-29

Locations

1 site across 1 country: China