Not Determined
Conditions
Keywords
sonrotoclax, BGB-11417, healthy volunteers, phenytoin, itraconazole
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.
Interventions
DRUGPhenytoin
Administered orally.
DRUGItraconazole
Administered orally.
DRUGsonrotoclax
Administered orally.
Sponsors
Quotient Sciences
BeiGene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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: Time to maximum observed concentration (Tmax) 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: 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: Apparent oral clearance (CL/F) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed