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Hepatic ImpairmentPhase 1NCT04755075

Surufatinib Hepatic Impairment Study

A Phase 1 study testing Surufatinib in people with Hepatic Impairment, run by Hutchison Medipharma Limited 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

An open-label, multicenter, single-dose, single-period, sequential study to determine the effect of hepatic impairment on the PK of surufatinib. 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?
Surufatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesUnited States
Study dates
12 Feb 2021to 11 Oct 2021
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 18 and 75 (inclusive)
  • Subject has BMI >18 and ≤40 kg/m^2 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 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 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.
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  • 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 disease status within the last 30 days before screening.
  • If diabetic, the subject must have the disease controlled
  • Subjects with ascites must not have a paracentesis within 3 months of screening.
  • The subject must have blood pressure between 90 and 160 mm Hg systolic, inclusive, and not higher than 100 mm Hg diastolic.
  • Subjects with Normal Hepatic Function
  • The subject must be without hepatic disease and have normal hepatic function
  • The subject must be in good health
  • The subject must have blood pressure between 95 and 150 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic

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 the 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).
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  • The subject has participated in a clinical study of another drug before dosing, 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 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 received blood or blood products within 8 weeks, or donated blood or blood products within 8 weeks prior to the first dose, or donated double red cells within 16 weeks prior to the first dose.
  • The subject has used any drug that is a strong inhibitor or inducer (including St. John's wort) of CYP3A or P-gp within 2 weeks prior to first dose or will require use during study treatment period.
  • The subject is allergic to the study drug or to any of its excipients.
  • Female subjects who are pregnant or planning to become pregnant, lactating, or breastfeeding.
  • 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.
  • Subjects with Hepatic Impairment
  • The subject has clinically significant vital sign abnormalities at screening or baseline.
  • 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
  • The subject has previously been diagnosed with hepatocellular carcinoma.
  • The subject has acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function
  • 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.
  • The subject has evidence of current or recent abuse of alcohol
  • The subject has received therapy known to exacerbate hepatic impairment within 4 weeks of study drug administration.
  • The subject is taking antiviral therapy for treatment of active hepatitis infection at the time of screening.
  • 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 baseline.
  • The subject tests positive for Hepatitis B virus (HBV), HBsAg, Hepatitis C virus (HCV), or Hepatitis C antibody
  • The subject has used any prescription or nonprescription drugs, including over-the-counter (OTC) medications or vitamins, within 2 weeks prior to the first dose, unless otherwise specified.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Orlando Clinical Research Center, Inc.

    Orlando, Florida, 32809

  • Orange County Research Center

    Tustin, California, 92780

Other trials in United States

About this study

Official title: A Phase 1 Study To Assess The Effect Of Hepatic Impairment On The Pharmacokinetics Of Surufatinib

An open-label, multicenter, single-dose, single-period, sequential study to determine the effect of hepatic impairment on the PK of surufatinib.

Read the detailed description

This is a phase 1, open-label, multicenter, single-dose, single-period, sequential study with the primary objective of determining the effect of moderate and mild hepatic impairment on the PK of surufatinib. The secondary objective is to evaluate the safety in subjects with moderate and mild (if enrolled) hepatic impairment and subjects with normal hepatic function.

Being tested
Surufatinib

What participants receive

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

  • SurufatinibDrug

    Also called HMPL-012

    Subjects to receive Surufatinib 250 mg on Day 1

  • SurufatinibDrug

    Also called HMPL-012

    Subjects to receive Surufatinib 250 mg on Day 1

Study groups in NCT04755075
Study groupRoleWhat they receive
Cohort 1ExperimentalSubjects with Normal Hepatic Function: All patients to receive study drug (Surufatinib 250mg) on Day 1
Receives: Drug: Surufatinib
Cohort 2ExperimentalSubjects with Moderate Hepatic Impairment: All patients to receive study drug (Surufatnib 250mg) on Day 1
Receives: Drug: Surufatinib
Cohort 3 (if enrolled)ExperimentalSubjects with Mild Hepatic Impairment: All patients to receive study drug (Surufatnib 250mg) on Day 1
Receives: Drug: Surufatinib

What is being measured

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

  1. AUC0-t

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

    Measured: From Day 1 to Day 7

  2. AUC0-inf

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

    Measured: From Day 1 to Day 7

  3. Cmax

    Maximum observed plasma concentration

    Measured: From Day 1 to Day 7

Secondary outcomes (1)

  1. Number of participants with treatment emergent adverse events as assessed by NCI CTCAE v5.0

    To evaluate the safety of a single dose of 250mg surufatinib administered in subjects with mild (if enrolled) and moderate hepatic impairment

    Measured: From Day 1 to Day 7

Timeline

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

  1. First posted15 Feb 2021
  2. Study start12 Feb 2021
  3. Primary completion11 Oct 2021
  4. Study completion11 Oct 2021

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04755075
Sponsor's protocol ID
2020-012-00US2
Status last verified
Aug 2022
First submitted
4 Feb 2021
Last updated
30 Aug 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 Surufatinib in people with Hepatic Impairment, run by Hutchison Medipharma Limited 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 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 30 Aug 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?

AUC0-t (time frame: From Day 1 to Day 7). 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 NCT04755075.

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 30 Aug 2022.

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