- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320409
A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects (HMPL-012)
May 6, 2020 updated by: Hutchison Medipharma Limited
A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200031
- Shanghai Xuhui Central Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sulfatinib ,after general diet
First cycle, single oral Sulfatinib after general diet intake; Second cycle, Sulfatinib before general diet intake.
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250mg Sulfatinib ,single dose,oral
Other Names:
|
Experimental: Sulfatinib, before general diet
First cycle, single oral Sulfatinib before general diet intake;Second cycle,single oral Sulfatinib after general diet intake
|
250mg Sulfatinib ,single dose,oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The following PK parameters will be derived from the plasma concentration-time profile of Sufatinib following administration
Time Frame: 1-3 days
|
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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AE (adverse event) will be summarized by type and severity
Time Frame: 1 day to the 14 days
|
1 day to the 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chen Yu, Dr., Xuhui Center Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
December 18, 2014
First Posted (Estimate)
December 19, 2014
Study Record Updates
Last Update Posted (Actual)
May 8, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014-012-00CH2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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