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A Food Effect Phase I Study of the Volitinib in Healthy Subjects (HMPL-504)

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ClinicalTrials.gov Identifier: NCT02017236
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date May 14, 2019
Study Start Date  ICMJE November 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
pharmacokinetics [ Time Frame: 1-3days after every drug administration ]
The following PK parameters will be derived from the plasma concentration-time profile of Volitinib 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);Apparent oral Clearance (CL/F);Apparent oral Volume of distribution (Vz/F);Other parameters, such as elimination half-life
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02017236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Safety [ Time Frame: 1 day to the 14days after every drug administration ]
AE(adverse event) will be summarized by type and severity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2013)
Urinal and fecal excretion ratio of Volitnib;renal clearance of Volitinib [ Time Frame: duriation the first day to the third day after every drug administration ]
Urinal and fecal excretion ratio of Volitnib, renal clearance of Volitinib;Preliminary metabolite profiling of Volitnib in healthy subjects, with preliminary understanding of the clearance mechanism of Volitinib in human
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Food Effect Phase I Study of the Volitinib in Healthy Subjects
Official Title  ICMJE A Single Center, Open-label, Randomized, Four-Sequence, Four-period Crossover Study to Investigate Food Effect on the Pharmacokinetics of Single Dose of Volitinib in Healthy Subjects
Brief Summary The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 600 mg Volitinib and its two major 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 600 mg Volitinib and its two major metabolites in healthy subjects and to assess the safety and tolerability of single doses of 600mg in healthy subjects.This study will be an open-label, randomized, four-period, crossover PK food effect study of Volitinib administered orally at 600 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 4 treatments,2 weeks follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Food Effect
  • Health Subjects
Intervention  ICMJE Drug: Volitinib
600mg Volitinib ,single dose,oral
Other Name: HMPL-504
Study Arms  ICMJE
  • Experimental: Volitinib ,after high fat meal intake
    A:single oral Volitinib after high fat meal intake
    Intervention: Drug: Volitinib
  • Experimental: Volitinib,after general diet
    B:single oral Volitinib, after general diet
    Intervention: Drug: Volitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
32
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males , between 18 and 45 years of age, inclusive.
  • Body mass index (BMI) within the range of 19 to 25 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, during the period from informed consent until 90 days following Study Completion, 1 of the following approved methods of contraception: a double barrier method (eg, male condom with spermicide, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, or use of a cervical cap with spermicide); a sterile sexual partner; a female sexual partner using an intravaginal system (eg,NuvaRing®); or a partner using an oral, implantable, transdermal, or injectable contraceptives.
  • Able to comprehend and willing to sign an informed consent form (ICF).

Exclusion Criteria:

  • Significant 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.
  • 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).
  • History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
  • Diagnosis of alcoholism or drug addiction within 1 year prior to Period 1 Check-in.
  • Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer prior to informed consent.
  • Use of any prescription medications or products within 14 days prior to Period 1 prior to informed consent.
  • Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic, herbal, dietary supplements, or plant derived preparations) within 7 days prior to each study period Check-in.
  • Use of alcohol-, grapefruit-, Seville orange-, or caffeine-containing foods, juices, or beverages within 72 hours prior to each study period Check-in.
  • 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 informed consent;
  • Poor peripheral venous access.
  • Donation of blood ≥ 250 mL from 30 days prior to informed consent until study completion, inclusive, or of plasma from 2 weeks prior to informed consent until study completion, inclusive.
  • Receipt of blood products within 2 months prior to Period 1 Check-in;
  • Blood pressure greater than 140/90 mmHg confirmed by repeat at Screening or at Period 1 Check-in.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02017236
Other Study ID Numbers  ICMJE 2013-504-CH1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hutchison Medipharma Limited
Study Sponsor  ICMJE Hutchison Medipharma Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chen yu Xuhui Center Hospital
PRS Account Hutchison Medipharma Limited
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP