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

NCT01955304 | Completed Phase 1 DMC

• 1 other identifier: 2012-013-00CH2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Effect of Fruquintinib in Health Subjects

Outcome Measures

Primary Outcomes (1)

• • To determine the effect of food on the PK of a single dose of 4mg fruquintinib in normal healthy subjects.

  Blood samples for PK analysis of serum fruquintinib levels will be collected for a 2-week period following each of 2 doses.

  Planned Enrollment/Screening Duration: Approximately 2 weeks. Length of Each Confinement: Approximately 7days prior to dose until approximately 120 hours postdose. Planned Study Conduct Duration: Approximately 6 weeks

Secondary Outcomes (1)

• • To assess the safety and tolerability of single doses of 4mg fruquintinib

  Planned Enrollment/Screening Duration: Approximately 2 weeks. Length of Each Confinement: Approximately 7days prior to dose until approximately 120 hours postdose. Planned Study Conduct Duration: Approximately 6 weeks

Study Arms (2)

A-fasted dosing followed by fed dosing

EXPERIMENTAL

Experimental: Fasted dosing of fruquintinib followed by fed dosing; Dosing in the fasted state followed by fed dosing

Drug: fruquintinib

B-fed dosing followed by fasted dosing

EXPERIMENTAL

Experimental: Fed dosing of fruquintinib followed by fasted dosing; Dosing in the fed state followed by fasted dosing

Drug: fruquintinib

Interventions

fruquintinib DRUG

Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks

Also known as: HMPL-013

A-fasted dosing followed by fed dosing; B-fed dosing followed by fasted dosing

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

Related Publications (1)

• Qian H, Fan S, Li K, Sai Y, Su W, Chen Q, Liu Y, Li T, Wang W, Jia J, Yu C, Liu Y. Effects of a High-fat Meal on the Pharmacokinetics of the VEGFR Inhibitor Fruquintinib: A Randomized Phase I Study in Healthy Subjects. Clin Ther. 2019 Aug;41(8):1537-1544. doi: 10.1016/j.clinthera.2019.05.014. Epub 2019 Jul 1.

  PMID: 31272709 DERIVED

MeSH Terms

Interventions

HMPL-013

Study Design

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

Study Record Dates

• First Submitted: September 28, 2013
• First Posted: October 7, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 17, 2020

Record last verified: 2013-05

Locations

CN (1)