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Renal ImpairmentPhase 1NCT05216354

Fruquintinib Renal Impairment Study

A Phase 1 study testing Fruquintinib in people with Renal Impairment, run by Hutchmed at 2 sites 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 multicenter, open label, single-dose, single-period, sequential study to assess the effect of renal impairment on the pharmacokinetics of Fruquintinib Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment
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
24 participants
Where
2 sitesUnited States
Study dates
11 Mar 2022to 26 Jun 2023
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Subjects
  • Male or female between the ages of 18 and 82 years old (inclusive)
  • BMI >18 and ≤40 kg/m2 and body weight not <50 kg at screening.
  • The subject is a non-smoker or light smoker who smokes no more than 10 cigarettes, 2 cigars, 2 pipes, or other nicotine equivalents (eg, vape, snuff, gum) of tobacco per day; willing to limit smoking during the treatment period to 4 cigarettes or 1 cigar per day.
  • Females must be of non-childbearing potential or surgically sterile
  • 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 treatment phase, 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.
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  • Subjects with Renal Impairment
  • For severe renal impairment, the subject must have CLcr of 15 to 29 mL/min at time of screening and day -1, as calculated by Cockcroft-Gault equation. For moderate renal impairment, the subject must have CLcr of 30 to 59 mL/min at time of screening and day -1, as calculated by Cockcroft-Gault equation. The difference between the screening and day -1 must be no more than 30%.
  • The subject must have no clinically significant change in clinical condition within the last 30 days before screening, as documented by the subject's recent medical history.
  • The subject must have a condition consistent with renal impairment and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator.
  • If diabetic, the subject must have the diabetes controlled (as determined by the Investigator).
  • Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed. Subjects must be on a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study.
  • Subjects with Normal Renal Function
  • The subject must be without renal disease and have normal renal function
  • The subject must be in good health

Who cannot join

  • All Subjects
  • The subject has evidence of clinically significant cardiovascular, hepatic, GI, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities.
  • The subject has a known history of any GI surgery or any condition possibly affecting drug absorption
  • The subject has a clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to day 1.
  • The subject has a clinically significant ECG abnormality.
  • The subject has been diagnosed with acquired immune deficiency syndrome (AIDS), or tests positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
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  • The subject has participated in a clinical study of another 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 before day 1, whichever is longer, or is currently enrolled in another clinical study.
  • The subject has consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior to day 1.
  • 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 day 1.
  • The subject has received blood or blood products within 8 weeks, or donated blood or blood products within 8 weeks prior to day 1 or donated double red cells within 16 weeks prior to day 1.
  • The subject has experienced a weight loss or gain of >10% within 4 weeks prior to day 1 as documented by recent medical history and weight at screening to check-in.
  • The subject has used any drug that is a strong inhibitor or inducer of CYP3A within 2 weeks (within 3 weeks for St. John's Wort) prior to day 1 or will require use during the treatment period.
  • The subject is allergic to the study drug or to any of its excipients.
  • Female subject who is pregnant or planning to become 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 them, 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.
  • Subjects with Renal Impairment
  • The subject has clinically significant vital sign abnormalities at screening or day -1.
  • The subject has used acetaminophen at doses >1 g/day within 2 weeks prior to study drug administration.
  • The subject has a history of drug or alcohol misuse within 6 months prior to screening or a positive drug test at screening or on day -1. A positive drug test may not be exclusionary if it is deemed to be the result of an approved prescribed concomitant medication.
  • The subject has clinically significant, laboratory, or ECG findings (apart from those parameters that are related to impaired renal function or underlying disease [eg, diabetes, hypertension]) that, in the opinion of the Investigator, may interfere with any aspect of the study conduct or interpretation of the results.
  • The subject has any history of renal transplant.
  • The subject has any known significant bleeding diathesis (eg, history of recent bleeding from esophageal varices) that could preclude multiple venipuncture or deep intramuscular injections.
  • The subject has acute or exacerbating renal disease, fluctuating or rapidly deteriorating renal function as indicated by widely varying or worsening of clinical and/or laboratory signs of renal impairment within 2 weeks of first dose.
  • The subject has systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg at screening or day -1
  • Subjects with Normal Renal Function
  • The subject has evidence of clinically significant renal disease or abnormalities.
  • 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
  • The subject has a history of drug or alcohol misuse within 6 months prior to screening or a positive drug test at screening or day -1
  • The subject has used any prescription or non-prescription drugs, including over-the-counter (OTC) medications or vitamins, within 2 weeks prior to day 1.
  • The subject has systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg at screening or day -1

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014-3616

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-Label, Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of Fruquintinib

A multicenter, open label, single-dose, single-period, sequential study to assess the effect of renal impairment on the pharmacokinetics of Fruquintinib

Read the detailed description

This is a multicenter, open label, single-dose, single-period, sequential study in subjects without cancer with the primary objective of determining the effect of severe and moderate renal impairment on the PK of Fruquintinib. The secondary objective is to evaluate the safety in subjects severe and moderate renal impairment and subjects with normal function.

Initially, subjects with severe renal impairment and subjects with moderate renal impairment will be enrolled. Subjects with normal renal function will be enrolled after all other subjects have completed the study and will be matched for sex, age and body mass index. Subjects with renal impairment will be enrolled based on the renal function classification determined by Cockcroft-Gault scoring.

Subjects with severe renal impairment will receive a single dose of 2 mg fruquintinib to account for potential increase in fruquintinib pharmacokinetic (PK) exposure. Subjects with moderate renal impairment or normal renal function will receive a single dose of 5 mg fruquintinib.

Being tested
Fruquintinib
Medical subject headings
Renal Insufficiency

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 dose on the morning of Day 1 under fasting conditions

Study groups in NCT05216354
Study groupRoleWhat they receive
Cohort 1 (healthy subjects)Experimental8 subject with normal renal function will be administered 5mg (1 x 5 mg capsule) fruquintinib
Receives: Drug: Fruquintinib
Cohort 2 (severe renal impairment)Experimental8 subjects with severe renal impairment will be administered 2 mg (2 x 1 mg capsules) fruquintinib
Receives: Drug: Fruquintinib
Cohort 3 (moderate renal impairment)Experimental8 subjects with moderate renal impairment will be administered 5 mg (a x 5 mg capsule) fruquintinib
Receives: Drug: Fruquintinib

What is being measured

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

  1. AUC 0-t

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

    Measured: Day 1 to Day 11

  2. AUC 0-inf

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

    Measured: Day 1 to Day 11

  3. Maximum Plasma Concentration [Cmax]

    To determine the maximum observed plasma concentration of Fruquintinib

    Measured: Day 1 to Day 11

Secondary outcomes (1)

  1. Incidence of AEs/SAEs

    Any untoward medical occurrence associated with the use of study drug

    Measured: Day 1 to Day 11

Timeline

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

  1. First posted31 Jan 2022
  2. Study start11 Mar 2022
  3. Primary completion26 Jun 2023
  4. Study completion26 Jun 2023

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
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216354
Sponsor's protocol ID
2021-013-00US2
Status last verified
Jul 2023
First submitted
19 Jan 2022
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fruquintinib in people with Renal Impairment, run by Hutchmed at 2 sites 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 15 inclusion and 31 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 (time frame: Day 1 to Day 11). 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 NCT05216354.

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 1 Aug 2023.

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