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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04163523




Registration number
NCT04163523
Ethics application status
Date submitted
5/11/2019
Date registered
14/11/2019

Titles & IDs
Public title
Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects
Scientific title
A Single Center, Phase I, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of BGB-3111 Given Orally at 320 mg QD in Healthy Adult Subjects
Secondary ID [1] 0 0
BGB-3111-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Treatment Sequence 1 - 5 Subjects received Period 1- 320 mg BGB-3111 administered after an overnight fast; Period 2- 320 mg BGB-3111 administered after High Fat/Calorie Meal; Period 3 - Day 15: 320 mg BGB-3111 administered after Low Fat/Calorie Meal

Experimental: Treatment Sequence 2 - 5 Subjects received Period 1 - Day 1: 320 mg BGB-3111 administered after High Fat/Calorie Meal; Period 2- Day 8: 320 mg BGB-3111 administered after Low Fat/Calorie Meal; Period 3- Day 15: 320 mg BGB-3111 administered after an overnight fast

Experimental: Treatment Sequence 3 - Approximately 5 Subjects receive Period 1-Day 1: 320 mg BGB-3111 administered after Low Fat/Calorie Meal; Period 2-Day 8: 320 mg BGB-3111 administered after an overnight fast; Period 3- Day 15: 320 mg BGB-3111 administered after High Fat/Calorie Meal
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-24))
Timepoint [1] 0 0
up to 24 hours
Primary outcome [2] 0 0
Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-8))
Timepoint [2] 0 0
up to 2 months
Primary outcome [3] 0 0
Pharmacokinetic Parameter: Peak Plasma Concentration (Cmax) of zanubrutinib
Timepoint [3] 0 0
up to 2 months
Primary outcome [4] 0 0
Pharmacokinetic Parameter: Time to Reach Peak Plasma Concentration (Tmax) of zanubrutinib
Timepoint [4] 0 0
up to 2 months
Primary outcome [5] 0 0
Pharmacokinetic Parameter: Half-life Period of zanubrutinib (T1/2)
Timepoint [5] 0 0
up to 2 months

Eligibility
Key inclusion criteria
1. Males and females between 18 to 65 years of age (inclusive)
2. Subjects must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study
3. Male subjects must agree to use a medically acceptable method of contraception from Screening until 90 days after administration of the last dose of study drug. Medically acceptable methods of contraception include the following: abstinence; a condom in addition to having the female partner use another form of contraception such as medically approved hormonal methods, diaphragm, intrauterine device or a tubal ligation. This requirement may be waived if the Principal Investigator or delegate is satisfied that the subject or partner is sterile (i.e., if female has undergone a hysterectomy, or has undergone a tubal ligation at least 3 months prior to Screening, or is postmenopausal (no menstrual period for at least 12 months prior to Screening); if male has undergone vasectomy at least 6 months prior to Screening). Male subjects agrees not to donate sperm for at least 90 days after administration of the last dose of study drug
4. Female subjects of non-childbearing potential measures, meeting at least one of the following criteria:

1. amenorrhoeal for 12 months (menopause confirmed by Follicular Stimulating Hormone (FSH) and Luteinising Hormone (LH) levels as defined by the established reference ranges), or
2. surgically sterile (e.g. hysterectomy, oophorectomy, tubal ligation for at least 3 months)
5. Males and females with a body mass Index (BMI) range 18-35 kg/m2 inclusive.
6. Subjects who are healthy as determined by pre-study medical history, physical examination, and 12-Lead ECG
7. Subjects who have clinical laboratory test results during the screening period that are within the reference ranges or are clinically acceptable to the Investigator
8. Subjects who test negative for HIV, HBV, and HCV by standard serologic tests must be negative at Screening
9. Subjects who test negative for drugs of abuse and alcohol tests at screening and admission
10. Subjects who are nonsmokers(ex-smokers should have quit smoking at least 6 months prior to screening)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects who have a history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders that, in the Investigator's opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug
2. Subjects who have a history of relevant drug hypersensitivity
3. Subjects who have a history of substance abuse, drug addiction or alcoholism
4. Subjects who consume more than 14 units of alcohol per week for women and 28 units of alcohol for men
5. A QTc at screening, check-in (all periods), and pre and post study drug dosing of greater than 450 msec for males and females
6. Subjects with the following laboratory abnormalities (at Screening and check-in of each period): a leucocyte count < 4.0x10^9/L, a neutrophil count of < 2.5x10^9, lymphocyte count < 1.2x10^9/L, Haemoglobin < 10 g/L, or transaminase levels (ALT, AST) > ULN
7. Subjects who have a significant infection, an acute infection such as influenza, coryzal symptoms, recent upper respiratory tract infection, or known inflammatory process at the time of screening and/or admission
8. Subjects who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhea, heartburn)
9. Subjects who have used prescription drugs within 14 days of first dosing, unless agreed as nonclinically relevant by the Investigator and BeiGene (hormone replacement therapy will be permitted)
10. Subjects who have used over the counter medication excluding routine vitamins and herbal supplements (paracetamol <2 grams/day is acceptable) but including mega dose vitamin therapy and St John's Wort within 7 days of first dosing and throughout the study, unless agreed as nonclinically relevant by the Investigator and BeiGene
11. Subjects who have used any investigational drug and /or participated in any clinical trial within 2 months of first dosing
12. Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing. Subjects should not donate blood while on the study and for at least 60 days after last dose of study medication
13. Subjects who have consumed food or beverage (including caffeine, alcohol, and grapefruit-containing products) known to interfere with cytochrome P450 within 48 hours prior to first study drug dose
14. Subjects who cannot communicate reliably with the investigator or are unlikely to co-operate with the requirements of the study

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/07/2016
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
William Novotony, MD
Address 0 0
Beigne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04163523