A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib

Study Overview
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Brief Summary
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This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.

Detailed Description
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In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.

Official Title
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Single-center, Open and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 300 mg /100 μCi [14C] Sulfatinib in Chinese Adult Male Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]Sulfatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written Informed Consent Form (ICF) Age of 18-50 (inclusive)； Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)； Exclusion Criteria: Laboratory tests (blood tests, blood biochemical tests [fasting], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators； Clinically significant abnormal ECG at screening and before screening； Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive； Human immunodeficiency virus (HIV) antibody positive； Treponema pallidum antibody positive.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is single centre, open label, single dose study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: [14C]Sulfatinib<br>This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast. | Drug: [14C]Sulfatinib<br>* 300 mg Sulfatinib with 100 µCi [14C]<br>* Other names: 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib | The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration. | Measured from the 0 hour to 216 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib | Maximum observed concentration, occurring at Tmax. | Measured from the 0 hour to 216 hours | 
| To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib | The time at which maximum plasma concentration (Cmax) is observed. | Measured from the 0 hour to 216 hours | 
| To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib | The time at which Half-life (t1/2) is observed. | Measured from the 0 hour to 216 hours | 
| To obtain mass balance data after a single oral dose of [14C] Sulfatinib | Quantitative analysis of total radioactivity in the excretion of Sulfatinib | Measured on the Day1 to Day15 | 
| To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib. | Adverse Event (AE) monitoring of [14C] Sulfatinib | Measured from the date signed ICF to within 15 days after the single dose |