Drug InteractionPhase 1NCT04645940
Fruquintinib Food Effect and Proton Pump Inhibitor Study
A Phase 1 study testing fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole and fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole in people with Drug Interaction and Food-drug Interaction, run by Hutchison Medipharma Limited at 1 site in United States.
Trial summary
The purpose of this is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction, Food-drug Interaction
- What is being tested?
- fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole and fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to 18 Nov 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive) at the time of informed consent.
- Body mass index (BMI) > 18 and ≤ 29 kg/m2 at Screening.
- Females must be of non-childbearing potential (eg, postmenopausal [defined as cessation of all menstrual periods for at least 1 year confirmed by follicle-stimulating hormone (FSH) test ≥ 40 UI/L] or surgically sterile by total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
- Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a medically acceptable method of contraception starting for at least 1 menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception, such as a condom with spermicide. Males who have had a successful vasectomy (confirmed azoospermia, documentation needed) require no additional contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Who cannot join
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal (GI), renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities.
- History of any GI surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, history of stomach or intestinal surgery or resection, except appendectomy and hernia repair will be allowed).
- Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
- Food allergy deemed clinically significant per PI.
- Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at Screening or Day -1 Check-in (baseline).
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at Screening or Day -1 Check-in (baseline).
Show all 24Show fewer
- Clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval > 480 msec), or has a family history of prolonged QTc syndrome or sudden death.
- Gilbert's syndrome as indicated by total bilirubin >upper limit of normal (ULN) and subsequent measurement of direct bilirubin is not within normal range.
- History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or subject's verbal report and confirmed by cotinine test at Screening and Check-In for any one of the treatment periods.
- History of drug or alcohol misuse within 6 months prior to Screening or a positive urine drug test at Screening or Check-in for any one of the treatment periods.
- Diagnosed with acquired immune deficiency syndrome (AIDS) or has performed tests that are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- Participated in a clinical study of other drug before screening, and the time since the last use of other study drug is less than 5 times the half-life or 4 weeks, whichever is longer, or the subject is currently enrolled in another clinical study.
- Consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior to the first dose.
- Consumed herbal preparations/medications, including, but not limited to kava, ephedra (ma huang), Ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng, within 7 days prior to the first dose.
- Weight loss or gain of > 10% within 4 weeks prior to the first dose.
- Received blood or blood products within 4 weeks, or donated blood or blood products within 8 weeks prior to the first dose or donated double red cell within 16 weeks prior to first dose.
- Used any over-the-counter (OTC) medications or prescription drugs within 2 weeks prior to the first dose.
- Used CYP3A inducers (including St. John's wort) or inhibitors within 2 weeks before Day 1.
- Allergic to any of the study drugs or to any of their excipients.
- Used a PPI within 4 days prior to the first dose or a histamine 2 (H2) receptor antagonist (H2 blocker) within 2 days prior to the first dose.
- Cannot abstain from using a PPI or an H2 blocker or locally acting antacids (eg, Gaviscon, Gelusil, Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums).
- Any condition that would make him or her, in the opinion of the investigator or sponsor, unsuitable for the study, or who, in the opinion of the investigator, is not likely to complete the study for any reason.
- Female subject is pregnant, lactating, or breastfeeding.
- Cannot consume study designed high-fat meal due to diet restrictions or being vegetarian/vegan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 3 Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of Fruquintinib in Healthy Subjects
The purpose of this is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.
Read the detailed description
This study will be a single center, open label, 3-period, randomized 2-sequence study conducted with 14 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods 1, 2, and 3), and an End of Study (EOS) Phase. For Periods 1 and 2, subjects will be randomized into 1 of the 2 treatment sequences, with all subjects then moving to the same treatment in Period 3.
Periods 1 and 2: 14 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 possible treatment sequences:
- Fed/Fasted: fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15
- Fasting/Fed: fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15
Period 3: all subjects will take rabeprazole 40 mg orally once daily in the morning from Day 23 to Day 29. On the morning of Day 29, all subjects will take rabeprazole 40 mg orally without food one hour before taking a fruquintinib 5 mg oral dose. Subjects will continue to fast until lunch.
- Conditions
- Drug Interaction, Food-drug Interaction
- Being tested
- fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole, fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazoleDrug
Also called HMPL-013, rabeprazole 40 mg
fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15.
40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.
fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazoleDrug
Also called HMPL-013, rabeprazole 40 mg
fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15.
40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.
| Study group | Role | What they receive |
|---|---|---|
| Fed/Fasted | Experimental | fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15. 40 mg rabeprazole from Day 23 to Day 29. On Day 29, fruquintinib 5 mg one hour after rabeprazole dose. Receives: Drug: fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole |
| Fasted/Fed | Experimental | fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15. 40 mg rabeprazole from Day 23 to Day 29. On Day 29, fruquintinib 5 mg one hour after rabeprazole dose. Receives: Drug: fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t) of fruquintinib: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration
Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
Measured: Up to 36 days
AUC(0-inf) of fruquintinib
Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity (if data permit)
Measured: up to 36 days
Cmax of fruquintinib
Pharmacokinetics of fruquintinib by assessment of maximum plasma fruquintinib concentration
Measured: up to 36 days
Secondary outcomes (1)
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
To evaluate the safety, in healthy subjects, of a single dose of 5 mg fruquintinib administered fed or fasted and with rabeprazole
Measured: up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start24 Sep 2020
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
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 Drug InteractionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Youngiun Kim, MD, Principal investigator, WCCT Global Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645940
- Sponsor's protocol ID
- 2020-013-00US1
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez M, Yang Z, Schelman WR, Zhou X, Gupta N, Chien C. Assessment of Food Effect and pH-Dependent Drug-Drug Interactions of Fruquintinib in Healthy Subjects. Clin Transl Sci. 2025 Mar;18(3):e70168. doi: 10.1111/cts.70168.
PubMed 40077903
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 3 Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of Fruquintinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04645940
- Acronym / sponsor ID
- 2020-013-00US1
- Conditions
- Drug Interaction, Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- 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.
The purpose of this is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.
Detailed description
This study will be a single center, open label, 3-period, randomized 2-sequence study conducted with 14 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods 1, 2, and 3), and an End of Study (EOS) Phase. For Periods 1 and 2, subjects will be randomized into 1 of the 2 treatment sequences, with all subjects then moving to the same treatment in Period 3.
Periods 1 and 2: 14 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 possible treatment sequences:
- Fed/Fasted: fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15
- Fasting/Fed: fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15
Period 3: all subjects will take rabeprazole 40 mg orally once daily in the morning from Day 23 to Day 29. On the morning of Day 29, all subjects will take rabeprazole 40 mg orally without food one hour before taking a fruquintinib 5 mg oral dose. Subjects will continue to fast until lunch.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed/Fasted | Experimental | Drug: fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazolefruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15. 40 mg rabeprazole from Day 23 to Day 29. On Day 29, fruquintinib 5 mg one hour after rabeprazole dose. |
| Fasted/Fed | Experimental | Drug: fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazolefruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15. 40 mg rabeprazole from Day 23 to Day 29. On Day 29, fruquintinib 5 mg one hour after rabeprazole dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive) at the time of informed consent.
- Body mass index (BMI) > 18 and ≤ 29 kg/m2 at Screening.
- Females must be of non-childbearing potential (eg, postmenopausal [defined as cessation of all menstrual periods for at least 1 year confirmed by follicle-stimulating hormone (FSH) test ≥ 40 UI/L] or surgically sterile by total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
- Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a medically acceptable method of contraception starting for at least 1 menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception, such as a condom with spermicide. Males who have had a successful vasectomy (confirmed azoospermia, documentation needed) require no additional contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Key exclusion criteria (24 listed)
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal (GI), renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities.
- History of any GI surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, history of stomach or intestinal surgery or resection, except appendectomy and hernia repair will be allowed).
- Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
- Food allergy deemed clinically significant per PI.
- Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at Screening or Day -1 Check-in (baseline).
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 |
|---|---|---|
| fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazoleAlso: HMPL-013, rabeprazole 40 mgfruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15. 40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29. | Drug | Fed/Fasted |
| fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazoleAlso: HMPL-013, rabeprazole 40 mgfruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15. 40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29. | Drug | Fasted/Fed |
Primary outcome
AUC(0-t) of fruquintinib: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration
Time frame: Up to 36 days
Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
AUC(0-inf) of fruquintinib
Time frame: up to 36 days
Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity (if data permit)
Cmax of fruquintinib
Time frame: up to 36 days
Pharmacokinetics of fruquintinib by assessment of maximum plasma fruquintinib concentration
1 secondary outcome
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: up to 36 days
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 18 Jun 2021.
- Derived from this study: PubMed 40077903Gonzalez M, Yang Z, Schelman WR, Zhou X, Gupta N, Chien C. Assessment of Food Effect and pH-Dependent Drug-Drug Interactions of Fruquintinib in Healthy Subjects. Clin Transl Sci. 2025 Mar;18(3):e70168. doi: 10.1111/cts.70168.
- Individual participant dataSharing planned: No
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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.
Youngiun Kim, MD principal investigator
WCCT Global Inc
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 with food/fruquintinib without food/fruquintinib with rabeprazole and fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole in people with Drug Interaction and Food-drug Interaction, run by Hutchison Medipharma Limited at 1 site in United States.
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 4 inclusion and 24 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 18 Jun 2021. 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 United States. 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?
AUC(0-t) of fruquintinib: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration (time frame: Up to 36 days). The study lists 3 primary outcomes in all. 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 NCT04645940, 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 18 Jun 2021.