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Metastatic Colorectal CancerPhase 1NCT05368805

Fruquintinib DDI Study With P-gp and BCRP Substrates

A Phase 1 study testing Fruquintinib, Dabigatran Etexilate and Rosuvastatin in people with Metastatic Colorectal Cancer, run by Hutchmed at 1 site in United States.

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

Fruquintinib DDI Study with P-gp and BCRP Substrates Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Fruquintinib, Dabigatran Etexilate and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
2 Mar 2022to 22 Apr 2022
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

  • The subject is male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
  • The subject has a body mass index (BMI) >18 and ≤29 kg/m2 at screening.
  • Female subjects must be of non-childbearing potential (eg, postmenopausal [defined as cessation of all menstrual periods for at least 1 year without an alternative medical cause, and confirmed by follicle-stimulating hormone (FSH) test ≥40 IU/L] or surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
  • Male subjects with partners of childbearing potential must always use a condom and must agree in addition to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include:
  • Oral hormonal contraception (combined estrogen/progestogen, or progestogen-only) associated with inhibition of ovulation
  • Intrauterine device (IUD)
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  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal ligation
  • Vasectomy
  • True sexual abstinence in line with the preferred and usual lifestyle of the subject.
  • Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with a spermicide).
  • The subject must provide written informed consent prior to any study-specific screening procedures.
  • The subject is willing and able to comply with all aspects of the protocol, as determined by the Investigator.

Who cannot join

  • Clinical laboratory test results from the coagulation panel (international normalized ratio [INR], prothrombin time, and activated partial thromboplastin time) must be within the normal laboratory reference ranges or deemed not clinically significant by the Investigator and Sponsor.
  • The subject has clinically significant renal laboratory findings, including estimated glomerular filtration rate <80 mL/min as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • The subject has a known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, history of stomach or intestinal surgery or resection). Appendectomy and hernia repair are allowed.
  • The subject had a clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
  • The subject has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at screening or at Day -1 check-in (baseline).
  • The subject has systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg.
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  • The subject has a clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval >480 msec), or had a family history of prolonged QTc syndrome or sudden death.
  • The subject has a 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 check in for each treatment period.
  • The subject has a history of drug or alcohol misuse within 6 months prior to screening or a positive urine drug test at screening or at check in for each treatment period.
  • The subject has been 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).
  • The subject has participated in a clinical trial 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 trial.
  • The subject has consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior to the first dose.
  • The subject has 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.
  • The subject has experienced a weight loss or gain of >10% within 4 weeks prior to the first dose as noted by medical history and weight at screening and check-in.
  • The subject has 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.
  • Clinical Study Protocol 2021-013-00US3 Fruquintinib Original Protocol HUTCHMED Limited Page 32 CONFIDENTIAL
  • The subject has used any over-the-counter (OTC) medications or prescription drugs that can affect gastric acid (proton pump inhibitors [PPIs], H2 blockers or locally acting antacids) or that inhibit CYP3A, P-gp, or BCRP in particular, within 2 weeks prior to the first dose.
  • Subject has used CYP3A inducers (including St John's wort) within 30 days before the first dose.
  • The subject is allergic to any of the study drugs (or its excipients) to be given in this study.
  • Female participant is pregnant, lactating, or breastfeeding.
  • Male subject who plans to donate sperm or father a child within 3 months after receiving the study drug.
  • The subject has 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.
  • One repeat of laboratory assessments may be performed at screening and check in at the discretion of the Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Development

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Open-label, 2-part, 2-period Fixed-sequence Study to Evaluate the Effect of Fruquintinib on the Pharmacokinetics of Dabigatran Etexilate (A P-GP Substrate) and Rosuvastatin (A BCRP Substrate) in Healthy Subjects

Fruquintinib DDI Study with P-gp and BCRP Substrates

Read the detailed description

A phase 1, open-label, 2-part, 2-period fixed-sequence study to evaluate the effect of Fruquintinib on the pharmacokinetics of Dabigatran Etexilate (A P-GP substrate) and Rosuvastatin (A BCRP substrate) in healthy subjects

Being tested
Fruquintinib, Dabigatran Etexilate, Rosuvastatin
Medical subject headings
Colorectal Neoplasms

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 will be administered as a single oral 5mg dose on the morning of day 5

  • Dabigatran EtexilateDrug

    Dabigatran Etexilate will be administered as a single oral dose 150mg on the morning of day 1 and morning of day 5

  • RosuvastatinDrug

    Rosuvastatin will be administered as a single oral dose 10mg on the morning of day 1 and the morning of day 5

Study groups in NCT05368805
Study groupRoleWhat they receive
Part AExperimentalOn Day 1, a single oral dose of dabigatran etexilate 150 mg will be given under fasted conditions and serial PK samples will be collected as indicated on the schedule of events. On Day 5, subjects will receive a single oral dose of fruquintinib 5 mg at approximately 1 hour prior to administration of a single oral dose of dabigatran etexilate 150 mg under fasted conditions and serial PK samples will be collected
Receives: Drug: Fruquintinib; Drug: Dabigatran Etexilate
Part BExperimentalOn Day 1, a single oral dose of rosuvastatin 10 mg will be given under fasted conditions and serial PK samples will be collected as indicated on the schedule of events. On Day 5, subjects will receive a single oral dose of rosuvastatin 10 mg with fruquintinib 5 mg under fasted conditions and serial PK samples will be collected
Receives: Drug: Fruquintinib; Drug: Rosuvastatin

What is being measured

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

  1. PK parameter for dabigatran and rosuvastatin: AUC0-t:

    area under the plasma concentration-time curve from time 0 to time of the last measurable concentration

    Measured: Day 1 to Day 13

  2. PK parameter for dabigatran and rosuvastatin: AUC0-inf:

    area under the plasma concentration-time curve from time 0 to infinity (if data permit)

    Measured: Day 1 to Day 13

  3. PK parameter for dabigatran and rosuvastatin: Cmax:

    maximum observed plasma concentration

    Measured: Day 1 to Day 13

Secondary outcomes (4)

  1. Incidence of AEs/SAEs

    Any untoward medical occurrence associated with the use of study drug

    Measured: Day 1 to Day 13

  2. PK parameter of fruquintinib and metabolite M11: AUC0-t:

    area under the plasma concentration-time curve from time 0 to time of the last measurable concentration

    Measured: Day 1 Day 13

  3. PK parameters of fruquintinib and metabolite M11: AUC0-inf:

    area under the plasma concentration-time curve from time 0 to infinity (if data permit)

    Measured: Day 1 to Day 13

  4. PK parameters of fruquintinib and metabolite M11: Cmax:

    maximum observed plasma concentration

    Measured: Day 1 to Day 13

Timeline

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

  1. First posted10 May 2022
  2. Study start2 Mar 2022
  3. Primary completion22 Apr 2022
  4. Study completion22 Apr 2022

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05368805
Sponsor's protocol ID
2021-013-00US3
Status last verified
Oct 2022
First submitted
21 Apr 2022
Last updated
6 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gonzalez M, Yang Z, Schelman WR, Zhou X, Gupta N, Chien C. A Phase 1 Study to Assess the Effect of Fruquintinib on the Pharmacokinetics of P-gp and BCRP Substrates in Healthy Subjects. Clin Transl Sci. 2025 Nov;18(11):e70408. doi: 10.1111/cts.70408.

    PubMed 41246975

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fruquintinib, Dabigatran Etexilate and Rosuvastatin in people with Metastatic Colorectal Cancer, run by Hutchmed 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 13 inclusion and 23 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 6 Oct 2022. 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?

PK parameter for dabigatran and rosuvastatin: AUC0-t: (time frame: Day 1 to Day 13). 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 NCT05368805, 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 6 Oct 2022.

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