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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627520
• Other study ID #: 2017-012-00CH1
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2019
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]Sulfatinib
300 mg Sulfatinib with 100 µCi [14C]

Locations

Country	Name	City	State
China	Hutchison Medipharma Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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