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Drug Drug InteractionPhase 1NCT04557397

Fruquintinib CYP3A Inhibitor and Inducer Study

A Phase 1 study testing Fruquintinib, Itraconazole and Rifampin in people with Drug Drug Interaction, run by Hutchison Medipharma Limited 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

A study to assess the effect of itraconazole, a strong CYP3A inhibitor, and the effect of rifampin, a strong CYP3A inducer, on the pharmacokinetics of fruquintinib in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Drug Drug Interaction
What is being tested?
Fruquintinib, Itraconazole and Rifampin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
2 Sep 2020to 18 Oct 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

  • The subject is a nonsmoking, healthy 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.
  • 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. Male subjects must confirm that female partners of childbearing potential agree to use one of the following medically accepted contraception from Screening through 2 weeks after administration of the last dose of study drug:
  • Hormonal contraception (as the partner will not be taking the study investigational product [IP]) along with male subject's condom with spermicide
  • Intrauterine device (hormonal or non-hormonal) along with male subject's condom with spermicide
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  • Bilateral tubal ligation
  • Depo Provera along with male subject's condom with spermicide Abstinence is allowed (6 months of true abstinence), including same sex partners.
  • However, if a subject becomes sexually active during the study or, in the case of same-sex partners, has a sexual relationship with a member of the opposite sex, the subject must agree to adhere to the requirements above.
  • 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

  • The subject has evidence of clinically significant cardiovascular, hepatic, gastrointestinal (GI), renal, respiratory, endocrine, hematological, neurological, or psychiatric diseases or abnormalities.
  • The subject has a known 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; appendectomy and hernia repair will be 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 Day -1 Check-in (baseline).
  • The subject has systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg at Screening or Day -1 Check-in (baseline).
  • 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 has a family history of prolonged QTc syndrome or sudden death.
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  • The subject has Gilbert's syndrome as indicated by total bilirubin > ULN and subsequent measurement of direct bilirubin is above normal range.
  • 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 Screening and Check-in for any one of the treatment periods.
  • 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 Check-in for any one of the treatment periods.
  • The subject has been diagnosed with acquired immune deficiency syndrome 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 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.
  • 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.
  • 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 the first dose.
  • The subject has used any over-the-counter (OTC) medications or prescription drugs within 2 weeks prior to the first dose.
  • The subject has used CYP3A inducers (including St. John's wort) or inhibitors within 2 weeks before Day 1.
  • The subject is allergic to any of the study drugs or to any of their excipients.
  • The subject has used a proton pump inhibitor (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.
  • The subject has a known allergy to azole antifungals (for Part A: itraconazole)
  • The subject cannot abstain from using a PPI or an H2 blocker or locally acting antacids (eg, Gaviscon, Gelusil, Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums).
  • 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.
  • Female subject is pregnant, lactating, or breastfeeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WCCT

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase 1 Open-label 2-Part 2-Period Fixed-sequence Crossover Study To Assess The Effect Of Itraconazole, A Strong CYP3A Inhibitor, And The Effect Of Rifampin, A Strong CYP3A Inducer, On Pharmacokinetics Of Fruquintinib In Healthy Subjects

A study to assess the effect of itraconazole, a strong CYP3A inhibitor, and the effect of rifampin, a strong CYP3A inducer, on the pharmacokinetics of fruquintinib in healthy subjects.

Read the detailed description

This study will be a single-center, open-label, 2-part, 2-period fixed sequence crossover study to be conducted with 28 healthy male and female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End of Study (EOS) Phase. Screening will occur within 21 days before the first study drug administration. There will be at least a 14-day washout of fruquintinib between treatment periods.

Part A: subjects will be administered fruquintinib alone in treatment Period 1 and in combination with itraconazole in treatment Period 2.

Part B: subjects will be administered fruquintinib alone in treatment Period 1 and in combination with rifampin in treatment Period 2.

Being tested
Fruquintinib, Itraconazole, Rifampin
Keywords
CYP3A

What participants receive

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

  • FruquintinibDrug

    Also called HMPL-013

    oral VEGFR inhibitor

  • ItraconazoleDrug

    a synthetic triazole antifungal agent

  • RifampinDrug

    a semisynthetic antibiotic derivative of rifamycin SV

Study groups in NCT04557397
Study groupRoleWhat they receive
Part AOtherSubjects will receive fruquintinib, alone and with itraconazole.
Receives: Drug: Fruquintinib; Drug: Itraconazole
Part BOtherSubjects will receive fruquintinib, alone and with rifampin.
Receives: Drug: Fruquintinib; Drug: Rifampin

What is being measured

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

  1. AUC (0-t) of fruquintinib

    Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration

    Measured: up to 26 days

  2. AUC (0-inf) of fruquintinib

    Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity

    Measured: up to 26 days

  3. Cmax of fruquintinib

    Pharmacokinetics of fruquintinib by assessment of maximum plasma fruquintinib concentration

    Measured: up to 26 days

Secondary outcomes (1)

  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 fruquintinib administered with and without food

    Measured: up to 26 days

Timeline

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

  1. First posted21 Sep 2020
  2. Study start2 Sep 2020
  3. Primary completion18 Oct 2020
  4. Study completion18 Oct 2020

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
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557397
Sponsor's protocol ID
2020-013-00US2
Status last verified
Aug 2020
First submitted
15 Sep 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fruquintinib, Itraconazole and Rifampin in people with Drug 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 11 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 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 (time frame: up to 26 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 NCT04557397.

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.

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