Status:
COMPLETED
Surufatinib DDI With a PPI and a CYP3A Inducer
Lead Sponsor:
Hutchison Medipharma Limited
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04510649
Start Date
July 9 2020
End Date
March 2 2021
Last Update
June 18 2021
Active Locations (1)
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1
West Coast Clinical Trials (WCCT)
Cypress, California, United States, 90630