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

Early Phase 1CompletedNCT03627520

Hutchison Medipharma Limited6 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]SulfatinibDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hutchison Medipharma Ltd.

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: Measured from the 0 hour to 216 hours

Secondary Outcomes

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

Maximum observed concentration, occurring at Tmax.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Measured from the date signed ICF to within 15 days after the single dose

Data from ClinicalTrials.gov

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