We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05093270
Recruitment Status : Completed
First Posted : October 26, 2021
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants

Condition or disease Intervention/treatment Phase
Not Determined Drug: BGB-23339 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : November 15, 2021
Actual Primary Completion Date : September 15, 2022
Actual Study Completion Date : December 26, 2022

Arm Intervention/treatment
Experimental: Part A Dose Escalation (Single Ascending Dose)
Up to 5 dose levels of BGB-23339 or Placebo
Drug: BGB-23339
Administered orally as a tablet

Drug: Placebo
Administered orally as a tablet

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
Drug: BGB-23339
Administered orally as a tablet

Drug: Placebo
Administered orally as a tablet

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)
Drug: BGB-23339
Administered orally as a tablet

Drug: Placebo
Administered orally as a tablet

Experimental: Part D (Food-Effect Study)
Three single dose levels of BGB-23339 under different feeding conditions
Drug: BGB-23339
Administered orally as a tablet




Primary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 7 weeks ]
  2. Number of participants with clinically significant changes from baseline in vital signs [ Time Frame: Up to approximately 4 weeks ]
    Vital signs include blood pressure and pulse rate

  3. Number of participants with clinically significant changes from baseline in clinical laboratory values [ Time Frame: Up to approximately 4 weeks ]
    Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis


Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
  2. Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only [ Time Frame: Up to approximately 4 weeks ]
  3. Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
  4. Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D [ Time Frame: Up to approximately 4 weeks ]
  5. Maximum observed plasma concentration (Cmax) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
  6. Time to maximum plasma concentration (Tmax) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
  7. Trough plasma concentration (Ctrough) for Parts A, B, and C [ Time Frame: Up to approximately 4 weeks ]
  8. Apparent terminal elimination half-life (t½) for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]
    in fed and fasted states for BGB-23339

  9. Apparent systemic clearance (CL/F) for Parts A, B, and C [ Time Frame: Up to approximately 4 weeks ]
  10. Apparent volume of distribution (Vz/F) for Parts A, B, and C [ Time Frame: Up to approximately 4 weeks ]
  11. Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D [ Time Frame: Up to approximately 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05093270


Locations
Layout table for location information
Australia, Queensland
Q-Pharm Pty Ltd
Herston, Queensland, Australia
Australia, Victoria
Nucleus Network Pty Ltd
Geelong, Victoria, Australia, 3220
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004
China, Qingdao
The Affiliated Hospital of Qingdao University
Huangdao, Qingdao, China, 266500
Sponsors and Collaborators
BeiGene
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05093270    
Other Study ID Numbers: BGB-23339-101
First Posted: October 26, 2021    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No