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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627520
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C]Sulfatinib Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is single centre, open label, single dose study
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018
Arms and Interventions
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Arm Intervention/treatment
[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 Name: 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib [ Time Frame: Measured from the 0 hour to 216 hours ]
    Maximum observed concentration, occurring at Tmax.

  2. To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib [ Time Frame: Measured from the 0 hour to 216 hours ]
    The time at which maximum plasma concentration (Cmax) is observed.

  3. To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib [ Time Frame: Measured from the 0 hour to 216 hours ]
    The time at which Half-life (t1/2) is observed.

  4. To obtain mass balance data after a single oral dose of [14C] Sulfatinib [ Time Frame: Measured on the Day1 to Day15 ]
    Quantitative analysis of total radioactivity in the excretion of Sulfatinib

  5. To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib. [ Time Frame: Measured from the date signed ICF to within 15 days after the single dose ]
    Adverse Event (AE) monitoring of [14C] Sulfatinib


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Age of 18-50 (inclusive), Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627520


Locations
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China, Shanghai
Hutchison Medipharma Ltd.
Shanghai, Shanghai, China, 201203
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Study Director: Ke LI, PhD Hutchison Medipharma Ltd.
More Information
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Additional Information:

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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT03627520    
Other Study ID Numbers: 2017-012-00CH1
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No