- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163523
Study to Evaluate the Effect of Food on the Pharmacokinetics of a BGB-3111 in Healthy Subjects
November 12, 2019 updated by: BeiGene
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Australia
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Adelaide, South Australia, Australia, 5000
- CMAX
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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Other Names:
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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
|
Other Names:
|
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
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-24))
Time Frame: up to 24 hours
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up to 24 hours
|
Pharmacokinetic Parameter: Plasma concentration of zanubrutinib as measured by area under concentration-time curve (AUC(0-∞))
Time Frame: up to 2 months
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up to 2 months
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Pharmacokinetic Parameter: Peak Plasma Concentration (Cmax) of zanubrutinib
Time Frame: up to 2 months
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up to 2 months
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Pharmacokinetic Parameter: Time to Reach Peak Plasma Concentration (Tmax) of zanubrutinib
Time Frame: up to 2 months
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up to 2 months
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Pharmacokinetic Parameter: Half-life Period of zanubrutinib (T1/2)
Time Frame: up to 2 months
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up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: William Novotony, MD, Beigne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 25, 2016
Primary Completion (ACTUAL)
July 21, 2016
Study Completion (ACTUAL)
July 21, 2016
Study Registration Dates
First Submitted
November 5, 2019
First Submitted That Met QC Criteria
November 12, 2019
First Posted (ACTUAL)
November 14, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BGB-3111-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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