Phase 1Recruiting

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

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

Sponsor
BeOne Medicines (Industry)
Enrolment
24 planned
Conditions
Healthy Adult Participants
Interventions
BGB-43395; Midazolam; Celecoxib; Dabigatran etexilate; Rosuvastatin
Ages
adults, older adults
Registry
NCT07820891

Full record on ClinicalTrials.gov

From the registry

This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.

Primary outcomes

  • Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
  • Area Under the Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast)
  • Maximum Observed Concentration (Cmax)
  • Time to Reach Maximum Observed Concentration (Tmax)

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered