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Completed

NCT Number: NCT03627520

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Hutchison Medipharma Ltd.

Shanghai, Shanghai Municipality, 201203, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]Sulfatinib

Drug

300 mg Sulfatinib with 100 µCi [14C]

Other names: 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hutchison Medipharma Limited

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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