Clinical trial NCT03627520: A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is single centre, open label, single dose study
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Measured from the 0 hour to 216 hours
Secondary outcomes:
measure: To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib
timeFrame: Measured from the 0 hour to 216 hours
measure: To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib
timeFrame: Measured from the 0 hour to 216 hours
measure: To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib
timeFrame: Measured from the 0 hour to 216 hours
measure: To obtain mass balance data after a single oral dose of [14C] Sulfatinib
timeFrame: Measured on the Day1 to Day15
measure: To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
timeFrame: Measured from the date signed ICF to within 15 days after the single dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hutchison Medipharma Ltd.
state: Shanghai
Study officials:
affiliation: Hutchison Medipharma Ltd.
name: Ke LI, PhD
role: STUDY_DIRECTOR
References: