Surufatinib DDI With a PPI and a CYP3A Inducer

NCT ID: NCT04510649

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2021-03-02

Brief Summary

The purpose of this is to evaluate the effect of proton pump inhibitor (rabeprazole) and the effect of a CYP3A inducer (rifampin) on the pharmacokinetics of Surufatinib.

Detailed Description

This study will be a single center, open-label, 2 part, 2 period fixed-sequence crossover study to be conducted with 28 healthy male and female subjects (part A and part B). Subjects will be enrolled in either part A or part B.

In Part A, subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rabeprazole in treatment Period 2.

In Part B, subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rifampin in treatment Period 2.

PK samples will be collected through out both study periods.Subjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15 (part A) and Day 16 (part B).

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Surufatinib and Rabeprazole (Part A)

Part A: Surufatinib 300 mg on study days 1 and 11 Rabeprazole 40 mg on study days 5 - 11

Group Type: EXPERIMENTAL

Part A

Intervention Type: DRUG

in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11

Surufatinib and Rifampin (Part B)

Part B: Surufatinib 300 mg on study days 1 and 12 Rifampin 600 mg on study days 5-15

Group Type: EXPERIMENTAL

Part B

Intervention Type: DRUG

in Part B, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 12 and receive Rifampin 600 mg single dose on study days 5 through 16

Interventions

Part A

in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11

Intervention Type: DRUG

Part B

in Part B, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 12 and receive Rifampin 600 mg single dose on study days 5 through 16

Intervention Type: DRUG

Other Intervention Names

Rabeprazole 30 mg; Rifampin 600 mg

Eligibility Criteria

Inclusion Criteria

• Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive)
• Body mass index (BMI) > 18 and ≤ 29 kg/m2
• 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 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.

Exclusion Criteria

• Evidence of clinically significant cardiovascular, hepatic, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities
• Known history of any GI surgery or any condition possibly affecting drug absorption, however appendectomy and hernia repair will be allowed
• Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to first dose
• Known food allergy deemed clinically significant.
• Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations
• Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
• Clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval > 480 msec), or had a family history of prolonged QTc syndrome or sudden death
• Has Gilbert's syndrome as indicated by total bilirubin > upper limit of normal (ULN) and subsequent measurement of direct bilirubin is not within normal range.
• History of smoking or use of nicotine-containing substances within the previous 2 months
• History of drug or alcohol misuse in the previous 6 months
• Diagnosed with acquired immune deficiency syndrome (AIDS) or has performed tests that are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
• Participated in a clinical trial of other drug and the last use of other study drug is less than 5 times the half-life or 4 weeks, whichever is longer, or the subject is currently enrolled in another clinical trial
• Consumes grapefruit, starfruit, Seville oranges, or their products within 7 days before first dose
• Consumes herbal preparations/medications, including, but not limited to kava, ephedra (ma huang), Ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days before first dose
• Weight loss or gain of > 10% within 4 weeks before first dose
• Received blood or blood products within 4 weeks, or donated blood or blood products within 8 weeks, or donated double red blood cells within 16 weeks before first dose
• Uses any over-the-counter (OTC) medications or prescription drugs within 2 weeks before first dose
• Uses CYP3A inducers (including St. John's wort) or inhibitors within 2 weeks before first dose
• Allergic to the study drugs (including rabeprazole or rifampin) or to any of the excipients
• Cannot abstain from using a proton pump inhibitor (PPI) or a histamine H2 receptor antagonist (H2 blocker) or locally acting antacids (eg, Gaviscon, Gelusil, Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums)
• Female participant is pregnant, lactating, or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hutchison Medipharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youngiun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

WCCT Global Inc.

Locations

West Coast Clinical Trials (WCCT)

Cypress, California, United States

Countries

United States

Other Identifiers

2020-012-00US1

Identifier Type: -

Identifier Source: org_study_id