Surufatinib Hepatic Impairment Study

NCT04755075 | Completed Phase 1 FDA Drug

• 1 other identifier: 2020-012-00US2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• AUC0-t

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

  From Day 1 to Day 7

• AUC0-inf

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

  From Day 1 to Day 7

• Cmax

  Maximum observed plasma concentration

  From Day 1 to Day 7

Secondary Outcomes (1)

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

  From Day 1 to Day 7

Study Arms (3)

Cohort 1

EXPERIMENTAL

Subjects with Normal Hepatic Function: All patients to receive study drug (Surufatinib 250mg) on Day 1

Drug: Surufatinib

Cohort 2

EXPERIMENTAL

Subjects with Moderate Hepatic Impairment: All patients to receive study drug (Surufatnib 250mg) on Day 1

Drug: Surufatinib

Cohort 3 (if enrolled)

EXPERIMENTAL

Subjects with Mild Hepatic Impairment: All patients to receive study drug (Surufatnib 250mg) on Day 1

Drug: Surufatinib

Interventions

Surufatinib DRUG

Subjects to receive Surufatinib 250 mg on Day 1

Also known as: HMPL-012

Cohort 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

Orange County Research Center

Tustin, California, 92780, United States

Location

Orlando Clinical Research Center, Inc.

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

surufatinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 15, 2021
• Study Start: February 12, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

US (2)