Human Mass Balance Study of HMS5552 in Healthy Subjects

Study Overview
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Brief Summary
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This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of [14C]-HMS5552.

Official Title
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An Open-Label, Single Center Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of 50 mg (90 uCi) [14C]-HMS5552 in Healthy Adult Male Subjects

Conditions
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Healthy Subject

Intervention / Treatment
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* Drug: HMS5552


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult, male 19-55 years of age Weight at least 50 kg, and BMI within the range of 18-30 kg/m2 Written informed consent must be obtained before any assessment is performed Exclusion Criteria: History or presence of clinically significant medical, surgical or psychiatric condition or disease in the opinion of the Investigator or designee which might significantly alter the absorption, distribution, metabolism and excretion of drugs. History or presence of alcoholism or drug abuse. Smoker. Abnormal bowel habits.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [C14]-labelled HMS5552<br> | Drug: HMS5552<br>* [14C]-labelled HMS5552<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity in blood, plasma urine and feces | Peak plasma concentration (Cmax) | Up to 168 hours | 
| Total radioactivity in blood, plasma urine and feces | Area under the plasma concentration versus time curve (AUC) | Up to 168 hours | 
| Total radioactivity in blood, plasma urine and feces | Time to reach Cmax (Tmax) | Up to 168 hours | 
| Total radioactivity in blood, plasma urine and feces | Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance) | Up to 168 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of HMS5552 and its metabolites in plasma, urine and feces | Peak plasma concentration (Cmax) | Up to 168 hours | 
| Number of participants with adverse events as a measure of safety and tolerability | Adverse events; Laboratory parameters; Vital signs, clinical signs and symptoms and physical examination, including changes from baseline; ECG evaluation | Up to 168 hours | 
| Concentrations of HMS5552 and its metabolites in plasma, urine and feces | Area under the plasma concentration versus time curve (AUC) | Up to 168 hours | 
| Concentrations of HMS5552 and its metabolites in plasma, urine and feces | Time to reach Cmax (Tmax) | Up to 168 hours |