A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • [14C] HDM1002

    Drug

    Administered orally

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: [14C] HDM1002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Predose up to Day 11 after administration of [14C] HDM1002
2

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.

Time frame
Predose up to Day 11 after administration of [14C] HDM1002
3

Plasma and whole blood AUC[0-t] of radioactivity

PK parameter : Area under the curve from time 0 to t hour

Time frame
Predose up to Day 11 after administration of [14C] HDM1002
4

Plasma and whole blood AUC[0-∞] of radioactivity

PK parameter : Area under the curve from time 0 hour to ∞

Time frame
Predose up to Day 11 after administration of [14C] HDM1002

Secondary outcomes

1

Plasma AUC[0-t] of HDM1002 and metabolites

PK parameter : Area under the curve from time 0 to t hour

Time frame
Predose up to Day 11 after administration of [14C] HDM1002
2

Plasma AUC[0-∞] of HDM1002 and metabolites

PK parameter : Area under the curve from time 0 hour to ∞

Time frame
Predose up to Day 11 after administration of [14C] HDM1002
3

Plasma Cmax of HDM1002 and metabolites

PK parameter : Maximum observed concentration

Time frame
Predose up to Day 11 after administration of [14C] HDM1002
4

Plasma Tmax of HDM1002 and metabolites

PK parameter : Time to maximum plasma concentration

Time frame
Predose up to Day 11 after administration of [14C] HDM1002

Other outcomes

Sponsors and contacts

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