AzTrials
AzTrials

Hepatic ImpairmentPhase 1NCT05216367

Fruquintinib Hepatic Impairment Study

A Phase 1 study testing Fruquintinib in people with Hepatic 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
Search all trials

Trial summary

An Open-label, Phase 1 Study to Assess the Effect of Hepatic 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
Hepatic 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
16 participants
Where
2 sitesUnited States
Study dates
11 Mar 2022to 25 Oct 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 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 75 years old (inclusive)
  • BMI >18 and ≤40 kg/m2 and body weight not <50 kg at screening.
  • 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.
Show all 16Show fewer
  • Subjects with Hepatic Impairment
  • For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9. For mild hepatic impairment, the subject must have a Child-Pugh score of 5 to 6
  • The subject must have no clinically significant change in clinical condition within the last 30 days before screening
  • The subject must have a condition consistent with hepatic impairment and associated symptoms but otherwise be determined to be in good health in the opinion of the Investigator.
  • Subjects with ascites must not have a paracentesis within 3 months of screening.
  • 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 hepatic 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 Hepatic Function
  • The subject must be without hepatic disease and have normal hepatic function
  • The subject must be in good health

Who cannot join

  • All Subjects
  • The subject has evidence of clinically significant cardiovascular, GI, renal, 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 first dose
  • 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).
Show all 40Show fewer
  • The subject has clinically significant renal laboratory findings, including estimated creatinine clearance <60 mL/min as calculated by the Cockcroft-Gault equation.
  • 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
  • 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 (excluding subjects with moderate hepatic impairment).
  • 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.
  • Subjects with Hepatic 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 or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study
  • The subject has Gilbert's syndrome, liver transplant, Wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening unless successfully treated with banding, known gastric varices, spontaneous bacterial peritonitis or paracentesis within 3 months before screening, cholestatic liver disease (eg, primary biliary cirrhosis or primary sclerosing cholangitis), history of biliary sepsis within the past 2 years, or a portosystemic shunt.
  • The subject has previously diagnosed with hepatocellular carcinoma.
  • The subject has acute or exacerbating hepatitis, fluctuating hepatic function, or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the Investigator or the Sponsor's medical monitor.
  • The subject has a history of drug 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 evidence of current or recent abuse of alcohol, which, in the Investigator's opinion, would compromise subject's safety or compliance with the study procedures or positive alcohol test at screening or on day -1
  • The subject has received therapy known to exacerbate hepatic impairment within 2 weeks of day 1.
  • The subject is taking antiviral therapy for treatment of active hepatitis infection at the time of screening.
  • The subject has presence of clinically significant laboratory findings at screening are exclusionary, particularly:
  • Hemoglobin <8.5 g/dL
  • Platelet count <25,000/mm3
  • ALT or AST >5× upper limit of normal (ULN)
  • Hepatitis B surface antigen (HBsAg) positive and/or Hepatitis B core antibody positive
  • The subject has systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at screening or day -1
  • Subjects with Normal Hepatic Function
  • The subject has evidence of clinically significant hepatic illness 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 tests positive for Hepatitis B virus (HBV) assessed by the HBsAg and/or Hepatitis B core antibody, Hepatitis C virus (HCV), or Hepatitis C antibody.
  • 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
  • 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 Hepatic Impairment on the Pharmacokinetics of Fruquintinib

An Open-label, Phase 1 Study to Assess the Effect of Hepatic 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 moderate and mild hepatic impairment on the PK of fruquintinib. The secondary objective is to evaluate the safety in subjects with moderate and mild (if enrolled) hepatic impairment and subjects with normal hepatic function.

Initially, subjects with moderate hepatic impairment will be enrolled. An interim pharmacokinetic (PK) analysis will be performed to evaluate the need to enroll subjects with mild hepatic impairment. Subjects with normal hepatic 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 hepatic impairment will be enrolled based on the hepatic function classification determined by Child-Pugh scoring.

Subjects with moderate hepatic impairment will receive a single dose of 2 mg fruquintinib to account for potential increase in fruquintinib PK exposure. Subjects with mild hepatic impairment or normal hepatic function will receive a single dose of 5 mg fruquintinib.

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 will be administered as a single oral dose on the morning of day 1 under fasting conditions

Study groups in NCT05216367
Study groupRoleWhat they receive
Cohort 1 (healthy subjects)Experimental8 healthy subjects with normal hepatic function will receive a single dose of 5 mg (1x5 mg) fruquintinib
Receives: Drug: Fruquintinib
Cohort 2 (moderate hepatic impairment)Experimental8 subjects with moderate hepatic impairment will receive a single dose of 2 mg (2 x 1 mg) fruquintinib
Receives: Drug: Fruquintinib
Cohort 3 (mild hepatic impairment)Experimental8 subjects with mild hepatic impairment will receive a single dose of 5 mg (1 x 5 mg) 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 Adverse Events/Serious Adverse Events

    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 completion25 Oct 2022
  4. Study completion25 Oct 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
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216367
Sponsor's protocol ID
2021-013-00US1
Status last verified
Oct 2022
First submitted
19 Jan 2022
Last updated
31 Oct 2022
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 Hepatic 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 16 inclusion and 40 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 31 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 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 NCT05216367.

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 31 Oct 2022; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in