Food Effect of Fruquintinib in Health SubjectsPhase 1NCT01955304

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

A Phase 1 study testing fruquintinib in people with Food Effect of Fruquintinib in Health Subjects, run by Hutchison Medipharma Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Food Effect of Fruquintinib in Health Subjects
What is being tested?: fruquintinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: Jun 2012to Dec 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Fruquintinib (HMPL-013) in Healthy Subjects

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

Read the detailed description

This study will be an open-label, randomized, two-period, crossover PK food effect study of fruquintinib administered orally at 4mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study.

For each of 2 study periods, subjects will be admitted to the clinical research unit (CRU) on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 4 mg fruquintinib in either the fasted or fed state. Subjects will remain at the CRU for at least 120 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring. Subjects will return to the CRU for safety assessment for up to 336 hours postdose.

Conditions: Food Effect of Fruquintinib in Health Subjects
Being tested: fruquintinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fruquintinibDrug
Also called HMPL-013
Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks

Study groups in NCT01955304
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

• 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.
Measured: 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
Safety will be assessed by physical exam, clinical laboratory evaluations and ECGs.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2012

First posted7 Oct 2013 (estimated)
Study startJun 2012
Primary completionSep 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Food Effect of Fruquintinib in Health SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01955304
Sponsor's protocol ID: 2012-013-00CH2
Status last verified: May 2013
First submitted: 28 Sep 2013
Last updated: 17 Feb 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 31272709

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Fruquintinib (HMPL-013) in Healthy Subjects
ClinicalTrials.gov ID: NCT01955304
Acronym / sponsor ID: 2012-013-00CH2
Conditions: Food Effect of Fruquintinib in Health Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Sep 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 7 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A-fasted dosing followed by fed dosing	Experimental	Drug: fruquintinibExperimental: Fasted dosing of fruquintinib followed by fed dosing; Dosing in the fasted state followed by fed dosing
B-fed dosing followed by fasted dosing	Experimental	Drug: fruquintinibExperimental: Fed dosing of fruquintinib followed by fasted dosing; Dosing in the fed state followed by fasted dosing

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fruquintinibAlso: HMPL-013Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks	Drug	A-fasted dosing followed by fed dosing, B-fed dosing followed by fasted dosing

Primary outcome

• To determine the effect of food on the PK of a single dose of 4mg fruquintinib in normal healthy subjects.
Time frame: 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
Blood samples for PK analysis of serum fruquintinib levels will be collected for a 2-week period following each of 2 doses.

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
Derived from this study: PubMed 31272709Qian 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fruquintinib in people with Food Effect of Fruquintinib in Health Subjects, run by Hutchison Medipharma Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• To determine the effect of food on the PK of a single dose of 4mg fruquintinib in normal healthy subjects. (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01955304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.