A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects (HMPL-012)

NCT02320409 | Completed Phase 1

• 1 other identifier: 2014-012-00CH2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Subjects

Outcome Measures

Primary Outcomes (1)

• The following PK parameters will be derived from the plasma concentration-time profile of Sufatinib following administration

  Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);elimination half-life

  1-3 days

Secondary Outcomes (1)

• AE (adverse event) will be summarized by type and severity

  1 day to the 14 days

Study Arms (2)

Sulfatinib ,after general diet

EXPERIMENTAL

First cycle, single oral Sulfatinib after general diet intake; Second cycle, Sulfatinib before general diet intake.

Drug: Sulfatinib

Sulfatinib, before general diet

EXPERIMENTAL

First cycle, single oral Sulfatinib before general diet intake;Second cycle,single oral Sulfatinib after general diet intake

Drug: Sulfatinib

Interventions

Sulfatinib DRUG

250mg Sulfatinib ,single dose,oral

Also known as: HMPL-012

Sulfatinib ,after general diet; Sulfatinib, before general diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

• 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.

  PMID: 32800383 DERIVED

MeSH Terms

Interventions

surufatinib

Study Officials

• Chen Yu, Dr.

  Xuhui Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

CN (1)