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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201203
      • Hutchison Medipharma Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: [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.	Drug: [14C]Sulfatinib; 300 mg Sulfatinib with 100 µCi [14C]; Other Names: 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hutchison Medipharma Limited
• Investigators: Study Director: Ke LI, PhD, Hutchison Medipharma Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017-012-00CH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No