A Food Effect Phase I Study of the Volitinib in Healthy Subjects

NCT02017236 | Completed Phase 1 DMC

• 1 other identifier: 2013-504-CH1
• Study Type: interventional
• Target: 25
• 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 600 mg Volitinib and its two major metabolites in healthy subjects.

Conditions

Food Effect; Health Subjects

Keywords

Food Effect; Health subjects

Outcome Measures

Primary Outcomes (1)

• pharmacokinetics

  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

  1-3days after every drug administration

Secondary Outcomes (1)

• Safety

  1 day to the 14days after every drug administration

Other Outcomes (1)

• Urinal and fecal excretion ratio of Volitnib;renal clearance of Volitinib

  duriation the first day to the third day after every drug administration

Study Arms (2)

Volitinib ,after high fat meal intake

EXPERIMENTAL

A:single oral Volitinib after high fat meal intake

Drug: Volitinib

Volitinib,after general diet

EXPERIMENTAL

B:single oral Volitinib, after general diet

Drug: Volitinib

Interventions

Volitinib DRUG

600mg Volitinib ,single dose,oral

Also known as: HMPL-504

Volitinib ,after high fat meal intake; Volitinib,after general diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine

Study Officials

• Chen yu

  Xuhui Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 20, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 14, 2019

Record last verified: 2013-12

Locations

CN (1)