A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects

Recruiting

Phase 1 Results N/A

Trial Description

This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with parameters like Cmax, AUC(INF), and AUC(0-T).

Conditions

Interventions

  • BMS-986141 Drug
    Intervention Desc: Single dose BMS-986141 and Multiple doses of Dilitazem
    ARM 1: Kind: Experimental
    Label: BMS-986141 and Dilitazem
  • Dilitazem Drug
    Intervention Desc: Single dose BMS-986141 and Multiple doses of Dilitazem
    ARM 1: Kind: Experimental
    Label: BMS-986141 and Dilitazem

Trial Design

  • Masking: Open Label
  • Purpose: Basic Science
  • Endpoint: Pharmacokinetics Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Maximum observed concentration (Cmax) Days 1-21 No
Primary Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Days 1-21 No
Primary Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) Days 1-21 No
Secondary Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last] Yes

Sponsors