A green tea-pazopanib pharmacokinetic interaction study in healthy participants
An investigation of the impact of concomitant green tea consumption on the pharmacokinetics of a single dose of pazopanib in healthy participants.
The University of Sydney
15 participants
Aug 20, 2025
Interventional
Conditions
Summary
This study aims to investigate whether the pharmacokinetics of pazopanib (i.e., the amount of pazopanib in the blood) changes when pazopanib is given alone and when given with a green tea extract tablet. Pazopanib is an anti-cancer drug that is approved by the Australian Therapeutic Goods Administration and has been used clinically in Australia since 2010. Many patients living with cancer are reported to use complementary and alternative medicines in conjunction with their anti-cancer treatment, with green tea commonly used. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 60 years old and are of European ancestry. Please note that this study will NOT be enrolling patients with cancer. Study details Participants will receive a single oral tablet of pazopanib on 2 separate occasions, separated by 14 days. The first dose is on Day 1 and the second dose is on Day 15. Participants will also be asked to take a single daily green tea extract tablet for 9 days (from Day 10 to Day 18). All participants will provide blood samples over a 96-hour period after each pazopanib dose for the measurement of pazopanib pharmacokinetics. All participants will be monitored to check for changes to their health, questioned about their wellbeing and will have their vital signs checked (e.g., heart rate, blood pressure, temperature). An electrocardiogram (ECG) will also be performed and blood samples will be collected for safety testing. It is hoped that this research will help to understand whether the effectiveness and safety of pazopanib could be impacted in patients consuming green tea with their anti-cancer medication.
Eligibility
Inclusion Criteria17
- Be able to give written informed consent. Participants must be able to understand the full nature and purpose of the study, including possible risks and adverse effects and agree to the restrictions and requirements of the study.
- Male or female aged 18-60 years of age (inclusive) at Screening.
- BMI between 18.5 and 30 kg/m2 (inclusive) at Screening.
- European geographic ancestry. Geographic ancestry will be self-reported and participants will be considered of European ancestry if they report that both biological parents and all 4 biological grandparents are descendent of the original peoples of Europe.
- Determined to be healthy in the opinion of the Principal Investigator (or delegate). This will be based on medical history review, vital signs measurement, physical examination, clinical laboratory tests and ECG.
- Female participants:
- a. Must be of non-childbearing potential i.e., surgically sterilised (documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, tubal ligation) at least 6 weeks before the Screening visit or post-menopausal (where post-menopausal is defined as no menses for 12 months without an alternative medical cause and a FSH level consistent with post-menopausal status, per local laboratory guidelines), or
- b. If of childbearing potential, must:
- i. Have a negative pregnancy test at the Screening visit (serum pregnancy test) and on admission to the clinical facility on Day -1 and Day 14 (urine pregnancy test).
- ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 30 days after the last dose of pazopanib.
- iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception confirmed at Screening) until at least 30 days after the last dose of pazopanib, if not exclusively in a same-sex relationship or abstinent as a lifestyle choice.
- Male participants must:
- a. Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of pazopanib.
- b. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from Screening until at least 90 days after the last dose of pazopanib.
- c. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from Screening until at least 90 days after the last dose of pazopanib.
- Have suitable venous access for blood sampling.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and protocol requirements and restrictions.
Exclusion Criteria21
- History of allergy or intolerances to green tea products/constituents or known hypersensitivity to pazopanib or any of ingredients of either tablet.
- History of anaphylaxis or other significant allergy which, in the opinion of the Principal Investigator (or delegate), would interfere with the participant’s ability to participate in the study.
- Participated in any other clinical studies with an investigational product within 30 days or 5-half-lives of the investigational product (whichever is longer) from the last day of participation prior to the Screening visit.
- Donated or lost > 500 mL of blood and/or blood products within 3 months before the Screening visit.
- Clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Principal Investigator (or delegate), including but not limited to:
- i. History or presence of cardiovascular, pulmonary (excluding resolved childhood asthma), hepatic (including Gilbert’s syndrome), renal, haematological, GI (including cholecystectomy), endocrine, immunologic, dermatologic, psychiatric (excluding non-hospitalised depression and anxiety), or neurological disease/disorder (excluding migraine), including any acute illness, within the past 3 months determined by the Principal Investigator (or delegate) to be clinically relevant or could negatively impact the ability to comply with all procedures.
- ii. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- iii. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
- iv. Liver function test results elevated >1.5-fold above the upper limit of normal for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), alkaline phosphatase, aspartate aminotransaminase or alanine transaminase.
- v. Renal impairment defined as estimated glomerular filtration rate <90 mL/min/1.73 m2 (based on serum creatinine calculation only).
- Have had major surgery or a blood transfusion within 1 year of Screening visit.
- History of surgery or hospitalisation within 3 months prior to Screening visit.
- Be unable to swallow oral medication.
- History of alcohol abuse, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study screening.
- Regularly consume more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer (4.9% alcohol/volume), 100 mL wine (12% Alcohol/Volume), or 30 mL spirit (40% Alcohol/Volume).
- Smokes more than 5 cigarettes per week or equivalent use of any nicotine-containing product per week.
- A female who is breastfeeding or planning to breastfeed from screening and for at least 30 days after the last pazopanib dose.
- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to study initiation on Day -1.
- Have had a vaccination within 30 days prior to Screening visit.
- Any other condition or prior therapy that in the opinion of the Principal Investigator (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
- Not willing or able to comply with all study assessments and adhere to the protocol schedule and protocol requirements and restrictions.
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Interventions
This is an open-label, single-dose, one-sequence crossover pharmacokinetic study in healthy adult participants. All participants will receive a single oral 200 mg tablet of pazopanib on Day 1 (Treatment Period 1) and on Day 15 (Treatment Period 2) of the study. The washout period between the two single pazopanib doses will be 14 days. In addition, all participants will take a single oral 833 mg green tea extract tablet each morning from Day 10 to Day 18. This study involves two treatment periods: Treatment Period 1: Pazopanib On the morning of Day 1, participants will be administered a single oral 200 mg tablet of pazopanib with 300 mL water. The participants are required to fast for 10 hours before and 4 hours after the pazopanib tablet is administered. Participants will also not drink water for 1 hour before and 2 hours after pazopanib administration (apart from the 300 mL water supplied for pazopanib administration). Pazopanib administration on Day 1 will occur within the clinical facility after an overnight stay, during which fasting and water restrictions will be monitored and pazopanib ingestion will be supervised by study staff. Treatment Period 2: Pazopanib & Green Tea Extract The participants will undergo a period of green tea extract pre-treatment for 5 days: all participants will consume a single oral 833 mg green tea extract tablet with 300 mL water on the mornings of Day 10, Day 11, Day 12, Day 13 and Day 14, at approximately the same time as the Day 1 pazopanib dose (± 1 hour). These tablets will be taken in the fasted state, at least 30 minutes prior to breakfast (no food for a minimum of 10 hours prior with water permitted). On these days, participants will self-administer the green tea extract tablets (provided in a Webster pack) according to the instructions provided and will also complete the daily adherence form provided. On the morning of Day 15, participants will be administered a single oral 833 mg green tea extract tablet followed closely by a single oral 200 mg tablet of pazopanib with 300 mL water (both tablets and the 300 mL water being consumed within 5 minutes). The participants are required to fast for 10 hours before and 4 hours after the pazopanib tablet is administered. Participants will not drink water for 1 hour before and 2 hours after pazopanib administration (apart from the 300 mL water supplied for pazopanib and green tea extract administration). Pazopanib and green tea extract administration on Day 15 will occur within the clinical facility after an overnight stay, during which fasting and water restrictions will be monitored and pazopanib & green tea extract ingestion will be supervised by study staff. Participants will also consume a single 833 mg oral green tea extract tablet with 300 mL water once daily on the mornings of Day 16, Day 17 and Day 18 at approximately the same time as the Day 15 pazopanib dose (± 1 hour). These tablets will be taken in the fasted state, at least 30 minutes prior to breakfast (no food for a minimum of 10 hours prior with water permitted). The green tea extract tablets on Days 16-18 will be taken at the clinical facility and will be supervised by study staff. All participants will commence Treatment Period 1 on Day 1 and Treatment Period 2 on Day 10.
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ACTRN12625000814471