Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 4mg fruquintinib in normal healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hutchison Medipharma Limited

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.