A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
Phase 1
Completed
- Conditions
- Not Determined
- Interventions
- Registration Number
- NCT06543043
- Lead Sponsor
- BeiGene
- Brief Summary
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Able to understand and sign a written informed consent
- Able and willing to comply with all study requirements
- Healthy males or healthy females of non-childbearing potential
- Agrees to use an adequate method of contraception
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
Exclusion Criteria
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
- Prior treatment with sonrotoclax
- Evidence of renal impairment at screening
- Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
- Current smokers and those who have smoked within the last 12 months
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- History of any drug or alcohol abuse in the past 2 years
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- History of clinically significant disorders as judged by the investigator
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: Itraconazole + Sonrotoclax Itraconazole Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants. Part B: Itraconazole + Sonrotoclax sonrotoclax Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants. Part A: Phenytoin + Sonrotoclax sonrotoclax Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants. Part A: Phenytoin + Sonrotoclax Phenytoin Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.
- Primary Outcome Measures
Name Time Method Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax Approximately 21 days for Part A and 11 days for Part B
- Secondary Outcome Measures
Name Time Method Parts A and B: Number of Participants with Adverse Events (AEs) From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B Number of participants with AEs and SAEs, including findings from vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory assessments.
Trial Locations
- Locations (1)
Quotient Sciences
🇺🇸Miami, Florida, United States