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

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

Treatments tested in this trial

  • [14C] HDM1002

Treatment groups

10 Participants
are divided into 1 treatment group