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

NCT03627520 | Completed Early Phase 1

• 1 other identifier: 2017-012-00CH1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

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

  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 Outcomes (5)

• To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib

  Measured from the 0 hour to 216 hours

• To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib

  Measured from the 0 hour to 216 hours

• To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib

  Measured from the 0 hour to 216 hours

• To obtain mass balance data after a single oral dose of [14C] Sulfatinib

  Measured on the Day1 to Day15

• 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

Study Arms (1)

[14C]Sulfatinib

OTHER

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

Interventions

[14C]Sulfatinib DRUG

300 mg Sulfatinib with 100 µCi \[14C\]

Also known as: 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib

[14C]Sulfatinib

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Age of 18-50 (inclusive), Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Hutchison Medipharma Ltd.

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Interventions

surufatinib

Study Officials

• Ke LI, PhD

  Hutchison Medipharma Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is single centre, open label, single dose study

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: August 13, 2018
• Study Start: April 2, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)