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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]Sulfatinib

• Registration Number: NCT03627520
• Lead Sponsor: Hutchison Medipharma Limited

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-13
• Study Start: 2018-04-02
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Provision of written Informed Consent Form (ICF)
2. Age of 18-50 (inclusive)；
3. Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)；

Exclusion Criteria

1. Laboratory tests (blood tests, blood biochemical tests [fasting], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators；
2. Clinically significant abnormal ECG at screening and before screening；
3. Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive；
4. Human immunodeficiency virus (HIV) antibody positive；
5. Treponema pallidum antibody positive.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]Sulfatinib	[14C]Sulfatinib	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.

Primary Outcome Measures

Name	Time	Method
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	Measured from the 0 hour to 216 hours	The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hutchison Medipharma Ltd.; 🇨🇳 Shanghai, Shanghai, China