The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Location status: Recruiting
NCT Number: NCT06576401
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.
Interested in participating?
Request Info18 year–45 year
Male
Interventional
Phase 1
Suzhou, Jiangsu, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Time frame: Predose up to Day 11 after 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
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C] HDM1002 in plasma, urine, and feces.
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Area under the curve from time 0 to t hour
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Area under the curve from time 0 hour to ∞
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Maximum observed concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Time to maximum plasma concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter: Half life
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Apparent Clearance
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Apparent volume of distribution
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Area under the curve from time 0 to t hour
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Area under the curve from time 0 hour to ∞
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Maximum observed concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Time to maximum plasma concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter: Half life
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Apparent Clearance
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Apparent volume of distribution
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Number of subjects reporting AEs
Contact information is provided by the study sponsor or research team.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Industry
A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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