Healthy Adult Participants
Conditions
Brief summary
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
Detailed description
BGB-43395 is a drug that blocks a protein called cyclin-dependent kinase 4 (CDK4). CDK4 is a type of protein that regulates cell growth and division and can drive uncontrolled tumor cell growth. BGB-43395 is being developed for the treatment of patients with advanced solid tumors. The purpose of this study is to test whether BGB-43395 has any significant drug interactions with midazolam, celecoxib, dabigatran, and rosuvastatin. The main goal of the study is to test whether BGB-43395 affects how other drugs are processed by the body. This study consists of 2 parts. In Part 1, healthy participants will receive midazolam and celecoxib alone and with BGB-43395. In Part 2, healthy participants will receive dabigatran and rosuvastatin alone and with BGB-43395. The study will enroll approximately 24 healthy adult participants. The overall time to participate in this study is up to 7 weeks. Blood samples will be taken at specific time points, as well as vital signs and electrocardiograms.
Interventions
DRUGBGB-43395
Administered orally
DRUGMidazolam
Administered orally
DRUGCelecoxib
Administered orally
DRUGDabigatran etexilate
Administered orally
DRUGRosuvastatin
Administered orally
Sponsors
BeOne Medicines
Fortrea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 32.0 kg/m\^2, inclusive. * In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram and vital signs measurements, and clinical laboratory assessments. * Participants must not be pregnant or lactating and must agree to use contraception.
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, or pulse rate \>100 or \<40 beats per minute. Note: Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf) | Samples will be collected predose and at specified timepoints, up to 10 days | AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin. |
| Area Under the Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) | Samples will be collected predose and at specified timepoints, up to 10 days | AUC0-tlast for midazolam, celecoxib, dabigatran, and rosuvastatin. |
| Maximum Observed Concentration (Cmax) | Samples will be collected predose and at specified timepoints, up to 10 days | Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin. |
| Time to Reach Maximum Observed Concentration (Tmax) | Samples will be collected predose and at specified timepoints, up to 10 days | Tmax for midazolam, celecoxib, dabigatran, and rosuvastatin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From first dose up to 17 days | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), clinical laboratory abnormalities, 12-lead electrocardiogram, vital signs measurement, and physical examination findings. |
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed