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HealthyPhase 1NCT02320409

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

A Phase 1 study testing Sulfatinib in people with Healthy, run by Hutchison Medipharma Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Sulfatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
Dec 2014to Apr 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Xuhui Central Hospital

    Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
Sulfatinib
Keywords
Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SulfatinibDrug

    Also called HMPL-012

    250mg Sulfatinib ,single dose,oral

Study groups in NCT02320409
Study groupRoleWhat they receive
Sulfatinib ,after general dietExperimentalFirst cycle, single oral Sulfatinib after general diet intake; Second cycle, Sulfatinib before general diet intake.
Receives: Drug: Sulfatinib
Sulfatinib, before general dietExperimentalFirst cycle, single oral Sulfatinib before general diet intake;Second cycle,single oral Sulfatinib after general diet intake
Receives: Drug: Sulfatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1-3 days

Secondary outcomes (1)

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

    Measured: 1 day to the 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJan 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02320409
Sponsor's protocol ID
2014-012-00CH2
Status last verified
May 2020
First submitted
16 Dec 2014
Last updated
8 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32800383

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sulfatinib in people with Healthy, run by Hutchison Medipharma Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The following PK parameters will be derived from the plasma concentration-time profile of Sufatinib following administration (time frame: 1-3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02320409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.

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