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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 : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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.

Condition or disease Intervention/treatment Phase
Food Effect Health Subjects Drug: Volitinib Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Volitinib ,after high fat meal intake
A:single oral Volitinib after high fat meal intake
Drug: Volitinib
600mg Volitinib ,single dose,oral
Other Name: HMPL-504

Experimental: Volitinib,after general diet
B:single oral Volitinib, after general diet
Drug: Volitinib
600mg Volitinib ,single dose,oral
Other Name: HMPL-504




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety [ Time Frame: 1 day to the 14days after every drug administration ]
    AE(adverse event) will be summarized by type and severity


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017236


Locations
China, Shanghai
Shanghai Xuhui Central Hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
Principal Investigator: Chen yu Xuhui Center Hospital

Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02017236     History of Changes
Other Study ID Numbers: 2013-504-CH1
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: December 2013

Keywords provided by Hutchison Medipharma Limited:
Food Effect
Health subjects