About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male, healthy adult;
Age of 18 to 45 years old (both inclusive);
Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.
Disqualifiers
Clinically significant diseases at the time of screening;
History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
History of acute cholecystitis attack within 3 months prior to screening;
Trial design
Single group
Treatments tested in this trial
[14C] HDM1002
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Plasma and whole blood AUC[0-t] of radioactivity
PK parameter : Area under the curve from time 0 to t hour
Plasma and whole blood AUC[0-∞] of radioactivity
PK parameter : Area under the curve from time 0 hour to ∞
Secondary outcomes
Plasma AUC[0-t] of HDM1002 and metabolites
PK parameter : Area under the curve from time 0 to t hour
Plasma AUC[0-∞] of HDM1002 and metabolites
PK parameter : Area under the curve from time 0 hour to ∞
Plasma Cmax of HDM1002 and metabolites
PK parameter : Maximum observed concentration
Plasma Tmax of HDM1002 and metabolites
PK parameter : Time to maximum plasma concentration
Sponsors and contacts
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