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Healthy VolunteersPhase 1NCT04163523

Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects

A Phase 1 study testing Zanubrutinib in people with Healthy Volunteers, run by BeiGene at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 1 study in healthy subjects to determine the effect of food on the pharmacokinetics of BGB-3111. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Zanubrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
5 sitesAustralia
Study dates
25 May 2016to 21 Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males and females between 18 to 65 years of age (inclusive)
  • 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
  • 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
  • Female subjects of non-childbearing potential measures, meeting at least one of the following criteria:
  • amenorrhoeal for 12 months (menopause confirmed by Follicular Stimulating Hormone (FSH) and Luteinising Hormone (LH) levels as defined by the established reference ranges), or
  • surgically sterile (e.g. hysterectomy, oophorectomy, tubal ligation for at least 3 months)
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  • Males and females with a body mass Index (BMI) range 18-35 kg/m2 inclusive.
  • Subjects who are healthy as determined by pre-study medical history, physical examination, and 12-Lead ECG
  • Subjects who have clinical laboratory test results during the screening period that are within the reference ranges or are clinically acceptable to the Investigator
  • Subjects who test negative for HIV, HBV, and HCV by standard serologic tests must be negative at Screening
  • Subjects who test negative for drugs of abuse and alcohol tests at screening and admission
  • Subjects who are nonsmokers(ex-smokers should have quit smoking at least 6 months prior to screening)

Who cannot join

  • 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
  • Subjects who have a history of relevant drug hypersensitivity
  • Subjects who have a history of substance abuse, drug addiction or alcoholism
  • Subjects who consume more than 14 units of alcohol per week for women and 28 units of alcohol for men
  • A QTc at screening, check-in (all periods), and pre and post study drug dosing of greater than 450 msec for males and females
  • 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
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  • 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
  • Subjects who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhea, heartburn)
  • 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)
  • 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
  • Subjects who have used any investigational drug and /or participated in any clinical trial within 2 months of first dosing
  • 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
  • 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
  • Subjects who cannot communicate reliably with the investigator or are unlikely to co-operate with the requirements of the study

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Austin Health

    Heidelberg, Victoria, 3084

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Nucleus Network

    Melbourne, Victoria, 3004

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

  • Cancer Care Wollongong

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

Official 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

Phase 1 study in healthy subjects to determine the effect of food on the pharmacokinetics of BGB-3111.

Read the detailed description

A randomized, crossover study to evaluate the effect of food on pharmacokinetics of BGB-3111 when administered in subjects either after a high fat/calorie meal or a low fat/calorie meal or after an overnight fast.

Being tested
Zanubrutinib
Keywords
Phase 1, pharmacokinetics safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanubrutinibDrug

    Also called BGB-3111

Study groups in NCT04163523
Study groupRoleWhat they receive
Treatment Sequence 1Experimental5 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
Receives: Drug: Zanubrutinib
Treatment Sequence 2Experimental5 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
Receives: Drug: Zanubrutinib
Treatment Sequence 3ExperimentalApproximately 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
Receives: Drug: Zanubrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-24))

    Measured: up to 24 hours

  2. Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-∞))

    Measured: up to 2 months

  3. Pharmacokinetic Parameter: Peak Plasma Concentration (Cmax) of zanubrutinib

    Measured: up to 2 months

  4. Pharmacokinetic Parameter: Time to Reach Peak Plasma Concentration (Tmax) of zanubrutinib

    Measured: up to 2 months

  5. Pharmacokinetic Parameter: Half-life Period of zanubrutinib (T1/2)

    Measured: up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2019
  2. Study start25 May 2016
  3. Primary completion21 Jul 2016
  4. Study completion21 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163523
Sponsor's protocol ID
BGB-3111-103
Status last verified
Nov 2019
First submitted
5 Nov 2019
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zanubrutinib in people with Healthy Volunteers, run by BeiGene at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-24)) (time frame: up to 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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