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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06342713




Registration number
NCT06342713
Ethics application status
Date submitted
26/03/2024
Date registered
2/04/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035
Scientific title
A Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants
Secondary ID [1] 0 0
BGB-45035-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Participants 0 0
Healthy Subjects 0 0
Healthy Volunteers 0 0
Autoimmune Diseases 0 0
Healthy Adult Participants 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-45035
Treatment: Drugs - Placebo

Experimental: Part A (Single Ascending Dose) - Part A is designed to assess the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic profile of BGB-45035 following single-ascending doses (SAD) in healthy participants.

Experimental: Part B (Multiple Ascending Dose) - Part B is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy participants.

Experimental: Part C (Chinese Substudy) - Part C is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy Chinese participants.

Experimental: Part D (Food Effect) - Part D is designed to assess the effect of food on BGB-45035 exposure.


Treatment: Drugs: BGB-45035
Administered orally

Treatment: Drugs: Placebo
Administered orally
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 1 year
Primary outcome [2] 0 0
Number of participants with clinically significant changes from baseline in clinical laboratory values
Timepoint [2] 0 0
Up to approximately 1 year
Primary outcome [3] 0 0
Number of participants with clinically significant changes from baseline in vital signs
Timepoint [3] 0 0
Up to approximately 1 year
Primary outcome [4] 0 0
Number of participants with clinically significant changes from baseline in cardiac conduction intervals
Timepoint [4] 0 0
Up to approximately 1 year
Secondary outcome [1] 0 0
Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast)
Timepoint [1] 0 0
Up to approximately 1 year
Secondary outcome [2] 0 0
Area under the plasma concentration time curve from time zero to infinite time (AUCinf)
Timepoint [2] 0 0
Up to approximately 1 year
Secondary outcome [3] 0 0
Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau)
Timepoint [3] 0 0
Up to approximately 1 year
Secondary outcome [4] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [4] 0 0
Up to approximately 1 year
Secondary outcome [5] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [5] 0 0
Up to approximately 1 year
Secondary outcome [6] 0 0
Trough plasma concentration (Ctrough)
Timepoint [6] 0 0
Up to approximately 1 year
Secondary outcome [7] 0 0
Half life (t½)
Timepoint [7] 0 0
Up to approximately 1 year
Secondary outcome [8] 0 0
Apparent systemic clearance (CL/F)
Timepoint [8] 0 0
Up to approximately 1 year
Secondary outcome [9] 0 0
Apparent volume of distribution (Vz/F)
Timepoint [9] 0 0
Up to approximately 1 year
Secondary outcome [10] 0 0
Accumulation Ratios
Timepoint [10] 0 0
Up to approximately 1 year

Eligibility
Key inclusion criteria
1. Healthy female participants of non-childbearing potential and/or male participants between the ages of 18 and 55 years inclusive (ages 18 and 45 years for Part C).
2. Female participants of non-childbearing potential must meet at least 1 of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum Follicle-Stimulating Hormone (FSH) level confirming the post-menopausal state.
2. Have undergone a documented hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. All other female participants (including females with tubal ligations) are considered to be of childbearing potential.
3. BMI of 18 to 32 kg/m2; and a total body weight > 50 kg (110 lbs).
4. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
5. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
6. Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 90 days after the last dose of study drug.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy or cholecystectomy).
3. A positive screen alcohol or drug screen.
4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening.
5. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer.

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

Study design
Purpose of the study
Treatment
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 administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Cmax Clinical Research - 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
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
ClinicalTrials@beigene.com
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/NCT06342713