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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05093270




Registration number
NCT05093270
Ethics application status
Date submitted
16/09/2021
Date registered
26/10/2021

Titles & IDs
Public title
First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
Scientific title
A First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Subjects
Secondary ID [1] 0 0
BGB-23339-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Not Determined 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-23339
Treatment: Drugs - Placebo

Experimental: Part A Dose Escalation (Single Ascending Dose) - Up to 5 dose levels of BGB-23339 or Placebo

Experimental: Part B Dose Escalation (Multiple Ascending Dose) - Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A

Experimental: Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) - Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)

Experimental: Part D (Food-Effect Study) - Three single dose levels of BGB-23339 under different feeding conditions


Treatment: Drugs: BGB-23339
Administered orally as a tablet

Treatment: Drugs: Placebo
Administered orally as a tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 7 weeks
Primary outcome [2] 0 0
Number of participants with clinically significant changes from baseline in vital signs
Timepoint [2] 0 0
Up to approximately 4 weeks
Primary outcome [3] 0 0
Number of participants with clinically significant changes from baseline in clinical laboratory values
Timepoint [3] 0 0
Up to approximately 4 weeks
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D
Timepoint [1] 0 0
Up to approximately 4 weeks
Secondary outcome [2] 0 0
Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only
Timepoint [2] 0 0
Up to approximately 4 weeks
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D
Timepoint [3] 0 0
Up to approximately 4 weeks
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D
Timepoint [4] 0 0
Up to approximately 4 weeks
Secondary outcome [5] 0 0
Maximum observed plasma concentration (Cmax) for Parts A, B, C and D
Timepoint [5] 0 0
Up to approximately 4 weeks
Secondary outcome [6] 0 0
Time to maximum plasma concentration (Tmax) for Parts A, B, C and D
Timepoint [6] 0 0
Up to approximately 4 weeks
Secondary outcome [7] 0 0
Trough plasma concentration (Ctrough) for Parts A, B, and C
Timepoint [7] 0 0
Up to approximately 4 weeks
Secondary outcome [8] 0 0
Apparent terminal elimination half-life (t½) for Parts A, B, C and D
Timepoint [8] 0 0
Up to approximately 4 weeks
Secondary outcome [9] 0 0
Apparent systemic clearance (CL/F) for Parts A, B, and C
Timepoint [9] 0 0
Up to approximately 4 weeks
Secondary outcome [10] 0 0
Apparent volume of distribution (Vz/F) for Parts A, B, and C
Timepoint [10] 0 0
Up to approximately 4 weeks
Secondary outcome [11] 0 0
Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D
Timepoint [11] 0 0
Up to approximately 4 weeks

Eligibility
Key inclusion criteria
1. Signed informed consent form (ICF) and able to comply with study requirements
2. Healthy men and/or women of no childbearing potential of age = 18 years and = 55 years on the day of signing the ICF (or the legal age of consent) for Parts A, B and D; of age= 18 years and = 45 years on the day of signing the ICF (or the legal age of consent) and of Chinese descent for Part C
3. Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
4. Body weight = 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
5. A nonsterile man with a female partner of childbearing potential must be willing to use a highly effective method of birth control from the time of study enrollment until 90 days after the last dose of study drug
6. A woman of no childbearing potential must meet at least one of the following criteria:

1. Postmenopausal status, defined as: cessation of regular menses for = 12 consecutive months (menopause confirmed by Follicular Stimulating Hormone [FSH] levels and Luteinizing Hormone [LH] levels as defined by the established reference ranges)
2. Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data
2. Abnormal blood pressure as determined by the investigator
3. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history = 2 months before randomization)
4. Any malignancies within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
5. Past or intended use of prescription medication = 14 days and over-the-counter (OTC) medication including herbal, vitamins and dietary supplements = 7 days before randomization
6. Live vaccine = 30 days, and/or vaccine of any type = 14 days before randomization
7. Has received an investigational product within the following time before randomization: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer)
8. Participation in a prior study that would result in loss of blood or blood products in excess of 500 mL within 56 days before randomization
9. Exposure to = 4 new chemical entities within 12 months before randomization
10. Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or = 3 months before randomization
11. Regular alcohol consumption = 3 months before randomization
12. Regular use of recreational drugs
13. Current use and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 14 days before randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
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
15/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/12/2022
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd - Geelong
Recruitment hospital [3] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Qingdao

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
Address 0 0
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/NCT05093270