Healthy Participants Clinical Trial
Official title:
A 3-Part, Open-Label Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole (Moderate Inhibitor of CYP2C9 and CYP3A), Itraconazole (Strong CYP3A Inhibitor), or Rifampin (Strong CYP3A and Moderate CYP2C9 Inducer) in Healthy Subjects
The purpose of this study is to determine the effects of concomitant administration with fluconazole, itraconazole, and rifampin on the pharmacokinetics (PK) of a single 20-mg dose of avatrombopag in healthy participants.
This study will be a single center, open-label, drug-drug interaction study in healthy
participants. The study will consist of 3 parts: In Part A, the effects of steady-state
dosing of a moderate inhibitor of CYP2C9 and CYP3A (fluconazole) on the single-dose PK of
avatrombopag will be assessed. In Part B, the effects of steady-state dosing of a strong
CYP3A inhibitor (itraconazole) on the single-dose PK of avatrombopag will be assessed. In
Part C, the effects of steady-state dosing of a strong CYP3A and moderate CYP2C9 inducer
(rifampin) on the single-dose PK of avatrombopag will be assessed.
Each Part of the study will consist of 2 phases: Pretreatment and Treatment. The
Pretreatment Phase will consist of 2 periods: Screening and Baseline Period 1.The Treatment
Phase will consist of 2 treatment periods: Treatment Period 1 (administration of a single
oral dose of avatrombopag 20 mg alone under fed conditions); and Treatment Period 2
(administration of oral doses of each inhibitor or inducer alone and concomitant
administration of a single oral dose of avatrombopag 20 mg with each inhibitor or inducer
[fluconazole in Part A, itraconazole in Part B, or rifampin in Part C] under fed
conditions).
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