Mass Balance Study of [14C]HSK31858 in Healthy Adult Male Chinese Subjects.
NCT Number: NCT06569784
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: [14C]HSK31858
Sponsor: Xizang Haisco Pharmaceutical Co., Ltd
Sex: MALE
Age: ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2024-10-30
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China

Summary:
This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31858 in healthy male subjects.

Primary Outcome Measures: Total radioactivity ecovery rates in urine, Total radioactivity ecovery rates in urine at each time interval., during periods of 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose|Total radioactivity ecovery rates in feces, Total radioactivity ecovery rates in feces at each time interval., during periods of 0-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose|Cumulative total radioactivity recovery rates, Cumulative total radioactivity recovery rates of \[14C\]HSK31858 in excretion (urine and faeces) accounting for total radiation drug dose., From the start of administration to 312 hours post-dose|Cmax of total radioactivity, The pharmacokinetic parameters of total radioactivity in plasma, From the start of administration to 312 hours post-dose|AUC(0-t) of total radioactivity, The pharmacokinetic parameters of total radioactivity in plasm, From the start of administration to 312 hours post-dose|AUC(0-∞) of total radioactivity, The pharmacokinetic parameters of total radioactivity in plasm, From the start of administration to 312 hours post-dose|%AUC, Human plasma parent drug and its metabolites as a percentage of total plasma radioactivity exposure, From the start of administration to 312 hours post-dose|% administered dose, Human urine and feces parent drug and its metabolites as a percentage of administered dose, From the start of administration to 312 hours post-dose|Identification of the main metabolites, Identification of the main metabolites of HSK31858 in plasma, urine, and feces., From the start of administration to 312 hours post-dose
Secondary Outcome Measures: AUC(0-t), The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma, From the start of administration to 312 hours post-dose|AUC(0-∞), The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma, From the start of administration to 312 hours post-dose|Cmax, The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma, From the start of administration to 312 hours post-dose|Tmax, The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma, From the start of administration to 312 hours post-dose|t1/2, The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma, From the start of administration to 312 hours post-dose|Mean Residence Time, The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma, From the start of administration to 312 hours post-dose|AEs, The incidence and severity of AEs, From the time of signing ICF to the end of follow-up，up to 14 days.