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Status:

COMPLETED

Surufatinib Hepatic Impairment Study

Lead Sponsor:

Hutchison Medipharma Limited

Conditions:

Hepatic Impairment

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

Brief Summary

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

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 suruf...

Eligibility Criteria

Inclusion

  • 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.
  • 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

Exclusion

  • 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).
  • 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.

Key Trial Info

Start Date :

February 12 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 11 2021

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04755075

Start Date

February 12 2021

End Date

October 11 2021

Last Update

August 30 2022

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Orange County Research Center

Tustin, California, United States, 92780

2

Orlando Clinical Research Center, Inc.

Orlando, Florida, United States, 32809