A Phase 1, Open-label, Fixed-sequence Trial in Healthy Participants to Assess the Drug Interaction Potential of BGB-43395 With A Drug Cocktail Representative for CYP3A4, CYP2C9, P-gp, and BCRP Substrates
BeOne Medicines
Summary
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
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 particip…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- 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 disor…
Interventions
- DrugBGB-43395
Administered orally
- DrugMidazolam
Administered orally
- DrugCelecoxib
Administered orally
- DrugDabigatran etexilate
Administered orally
- DrugRosuvastatin
Administered orally
Location
- Fortrea CRUDallas, Texas