A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
NCT Number: NCT06576401
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Adult Subject
Interventions: DRUG: [14C] HDM1002
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-27
Completion Date: 2024-12
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Summary:
In this study, a single dose of \[14C\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] HDM002.

Primary Outcome Measures: Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002, Total recovery of radioactivity in urine and feces, and both routes combined expressed as a percentage of the total radioactive dose administered, Predose up to Day 11 after administration of [14C] HDM1002|Metabolite profiling/identification in plasma, urine, and feces, Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-06882961 and the metabolites of \[14C\] HDM1002 in plasma, urine, and feces., Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood AUC[0-t] of radioactivity, PK parameter : Area under the curve from time 0 to t hour, Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood AUC[0-∞] of radioactivity, PK parameter : Area under the curve from time 0 hour to ∞, Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood Cmax of radioactivity, PK parameter : Maximum observed concentration, Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood Tmax of radioactivity, PK parameter : Time to maximum plasma concentration, Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood t1/2 of radioactivity, PK parameter: Half life, Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood CL/F of radioactivity, PK parameter : Apparent Clearance, Predose up to Day 11 after administration of [14C] HDM1002|Plasma and whole blood Vz/F of radioactivity, PK parameter : Apparent volume of distribution, Predose up to Day 11 after administration of [14C] HDM1002|Percentage of plasma HDM1002 and metabolites in total plasma radioactivity, Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC, Predose up to Day 11 after administration of [14C] HDM1002
Secondary Outcome Measures: Plasma AUC[0-t] of HDM1002 and metabolites, PK parameter : Area under the curve from time 0 to t hour, Predose up to Day 11 after administration of [14C] HDM1002|Plasma AUC[0-∞] of HDM1002 and metabolites, PK parameter : Area under the curve from time 0 hour to ∞, Predose up to Day 11 after administration of [14C] HDM1002|Plasma Cmax of HDM1002 and metabolites, PK parameter : Maximum observed concentration, Predose up to Day 11 after administration of [14C] HDM1002|Plasma Tmax of HDM1002 and metabolites, PK parameter : Time to maximum plasma concentration, Predose up to Day 11 after administration of [14C] HDM1002|Plasma t1/2 of HDM1002 and metabolites, PK parameter: Half life, Predose up to Day 11 after administration of [14C] HDM1002|Plasma CL/F of HDM1002 and metabolites, PK parameter : Apparent Clearance, Predose up to Day 11 after administration of [14C] HDM1002|Plasma Vz/F of HDM1002 and metabolites, PK parameter : Apparent volume of distribution, Predose up to Day 11 after administration of [14C] HDM1002|Adverse events (AEs), Number of subjects reporting AEs, Predose up to Day 11 after administration of [14C] HDM1002