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Trial registered on ANZCTR


Registration number
ACTRN12625000814471
Ethics application status
Approved
Date submitted
15/07/2025
Date registered
30/07/2025
Date last updated
30/07/2025
Date data sharing statement initially provided
30/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A green tea-pazopanib pharmacokinetic interaction study in healthy participants
Scientific title
An investigation of the impact of concomitant green tea consumption on the pharmacokinetics of a single dose of pazopanib in healthy participants.
Secondary ID [1] 313301 0
PAZ-GT-1
Universal Trial Number (UTN)
Trial acronym
PAZ-GT PK Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal cell carcinoma 335481 0
Soft Tissue Sarcoma 338283 0
Condition category
Condition code
Alternative and Complementary Medicine 332040 332040 0 0
Herbal remedies
Cancer 334586 334586 0 0
Kidney
Cancer 334587 334587 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329763 0
Treatment: Drugs
Comparator / control treatment
Pazopanib alone
Control group
Active

Outcomes
Primary outcome [1] 339642 0
To compare the pharmacokinetics of a single oral 200 mg dose of pazopanib in healthy participants with and without daily consumption of a green tea extract tablet.
Timepoint [1] 339642 0
Blood samples for pharmacokinetic analysis will be collected on Days 1 to 5 (Treatment Period 1) and Days 15 to 19 (Treatment Period 2), at pre-dose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 24, 48, 72 and 96 hours post-pazopanib dose.
Secondary outcome [1] 440711 0
To evaluate the safety and tolerability (composite secondary outcome) of a single 200 mg oral dose of pazopanib in healthy participants with and without daily consumption of a green tea extract tablet.
Timepoint [1] 440711 0
Any untoward event occurring from Day 1 until the follow-up assessment (occurring within 7 days of Day 20) will be recorded and considered a treatment-emergent adverse event.

Eligibility
Key inclusion criteria
1. 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.
2. Male or female aged 18-60 years of age (inclusive) at Screening.
3. BMI between 18.5 and 30 kg/m2 (inclusive) at Screening.
4. 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.
5. 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.
6. 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.
7. 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.
8. Have suitable venous access for blood sampling.
9. Willing and able to comply with all study assessments and adhere to the protocol schedule and protocol requirements and restrictions.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of allergy or intolerances to green tea products/constituents or known hypersensitivity to pazopanib or any of ingredients of either tablet.
2. 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.
3. 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.
4. Donated or lost > 500 mL of blood and/or blood products within 3 months before the Screening visit.
5. 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).
6. Have had major surgery or a blood transfusion within 1 year of Screening visit.
7. History of surgery or hospitalisation within 3 months prior to Screening visit.
8. Be unable to swallow oral medication.
9. History of alcohol abuse, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study screening.
10. 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).
11. Smokes more than 5 cigarettes per week or equivalent use of any nicotine-containing product per week.
12. A female who is breastfeeding or planning to breastfeed from screening and for at least 30 days after the last pazopanib dose.
13. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to study initiation on Day -1.
14. Have had a vaccination within 30 days prior to Screening visit.
15. 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.
16. Not willing or able to comply with all study assessments and adhere to the protocol schedule and protocol requirements and restrictions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Demographic data, including age, geographic ancestry, sex at birth, height, weight and BMI will be summarised using descriptive statistics.

Pazopanib pharmacokinetic parameters will be derived based on noncompartmental methods. Pazopanib pharmacokinetic parameters will be expressed as geometric means and 90% confidence intervals unless otherwise noted. The median with the range will be reported for nonparametric data. Statistical analyses will be performed (e.g., ANOVA, paired t-tests and Wilcoxon signed-rank test), as appropriate. A value of P <= 0.05 will be considered statistically significant.

All adverse events will be coded using the latest version of MedDRA. The number and percentage of participants with at least one treatment-emergent adverse event, will be summarised. This will also include the severity and relationship to pazopanib/green tea extract dosing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27242 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 43323 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317639 0
University
Name [1] 317639 0
The University of Sydney
Country [1] 317639 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319952 0
None
Name [1] 319952 0
Address [1] 319952 0
Country [1] 319952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316337 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316337 0
Ethics committee country [1] 316337 0
Australia
Date submitted for ethics approval [1] 316337 0
Approval date [1] 316337 0
10/07/2025
Ethics approval number [1] 316337 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137574 0
Dr Thomas Polasek
Address 137574 0
CMAX Clinical Research, Ground Floor, 21-24 North Terrace Adelaide, South Australia, 5000
Country 137574 0
Australia
Phone 137574 0
+61 458 162 715
Fax 137574 0
Email 137574 0
[email protected]
Contact person for public queries
Name 137575 0
Prof Andrew McLachlan
Address 137575 0
Sydney Pharmacy School A15, Faculty of Medicine and Health, The University of Sydney, NSW 2006, Australia
Country 137575 0
Australia
Phone 137575 0
+61 2 9351 4452
Fax 137575 0
Email 137575 0
[email protected]
Contact person for scientific queries
Name 137576 0
Prof Andrew McLachlan
Address 137576 0
Sydney Pharmacy School A15, Faculty of Medicine and Health, The University of Sydney, NSW 2006, Australia
Country 137576 0
Australia
Phone 137576 0
+61 2 9351 4452
Fax 137576 0
Email 137576 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.