Clinical trial NCT02320409: A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects (HMPL-012)
Official title: A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 250 mg Sulfatinib and its metabolites in healthy subjects.

Detailed description: The purpose of this study is to evaluate to determine the effect of food on the PK( pharmacokinetics) of a single dose of 250 mg Sulfatinib and its metabolites in healthy subjects and to assess the safety and tolerability of single doses of 250mg in healthy subjects.This study will be an open-label, randomized, two-period, crossover PK food effect study of Sulfatinib administered orally at 250 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 2 treatments,2 weeks follow-up.

Eligibility criteria: Inclusion Criteria:

* Males , between 18 and 55 years of age, inclusive.
* Body mass index (BMI) within the range of 20 to 30 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs.
* Adequate hepatic, renal, heart, and hematologic functions
* Male subjects who are either sterile or agree to use and get the agreement of their sexual partners to use , during the period from informed consent until 90 days following Study Completion, 1 of the following approved methods of contraception: condom, use by female sexual partner of an intrauterine device, contraceptive sponge, diaphragm, or use of a cervical cap; or an oral, implantable, transdermal, injectable contraceptives or other contraceptive measures.
* Able to comprehend and willing to sign an informed consent form (ICF).

Exclusion Criteria:

* disease history or clinical manifestation of any significant metabolic/endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric disorder(as determined by the Investigator).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
* serum total bilirubin\>34.2 umol/L；
* serum albumin\<35 g/L；
* GFR \< 80 mL/min/1.73m2. Algorithm: GFR (mL/min/1.73m2) =186 × (SCr)-1.154 × (Age)-0.203, Scr= serum creatinine, mg/dL；
* Blood pressure greater than 140/90.
* History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
* Smoking more than 10 cigarettes daily without intention to quit smoking during study.
* History of stomach or intestinal surgery, nephrectomy, cholecystectomy or resection that would potentially alter absorption and/or excretion of orally administered drugs as determined by the investigator (appendectomy and/or hernia repair may be allowed).
* Significant allergy history(eg. drug allergy); acute allergic rhinitis or food allergy within 2 weeks prior to informed consent.
* Donation of blood or plasma ≥ 500 mL from 30 days prior to informed consent, or of blood or plasma ≥250 mL from 2 weeks prior to informed consent.
* Receipt of blood products within 2 months prior to informed consent;
* Poor peripheral venous access.
* Participants who are positive for hepatitis B surface antigen (HBs antigen) or hepatitis B core antibody , hepatitis C virus (HCV) antibody;
* Participants who are human immunodeficiency virus (HIV)-positive;
* Diagnosis of alcoholism or drug addiction within 1 year prior to informed consent.
* Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 5 half-lives or 28 days, whichever is longer prior to informed consent.
* Use of any prescription medications or products within 14 days prior to informed consent.
* Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic, herbal,) within 7 days prior to informed consent.
* Use of alcohol-, grapefruit-, Seville orange-, or caffeine-containing foods, juices, or beverages within 72 hours prior to informed consent.
* Use of known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, or herbal/plant derived preparations such as St. John's Wort, etc.) for a period of 60 days prior to first dose;
* principal investigator, investigator, pharmacist, Clinical Research Coordinator or any personnel related to this study.
* Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.

Primary outcomes:
measure: The following PK parameters will be derived from the plasma concentration-time profile of Sufatinib following administration
timeFrame: 1-3 days
Secondary outcomes:
measure: AE (adverse event) will be summarized by type and severity
timeFrame: 1 day to the 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
affiliation: Xuhui Center Hospital
name: Chen Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qian H, Wu X, Chen Q, Li T, Wang W, Jia J, Yu C, Li K, Sai Y, Su W, Liu Y. Effects of Food on the Pharmacokinetic Properties of Surufatinib: A Phase I, Single-dose, Randomized, Open-label Crossover Study in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1778-1786. doi: 10.1016/j.clinthera.2020.07.010. Epub 2020 Aug 13.