Surufatinib DDI With a PPI and a CYP3A Inducer

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04510649

Run by

Hutchison Medipharma Limited

People needed

28

Starts

2020-07-09

Expected to finish

2021-03-02

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• West Coast Clinical Trials (WCCT) — Cypress, California, United States

Full record on ClinicalTrials.gov

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