A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395

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.

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 exclusion criteria may apply.