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Phase 1Completed

Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145 (DDI)

A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects

Sponsor
SecuraBio (Industry)
Enrollment
14 enrolled
Conditions
Healthy
Interventions
IPI-145; Rifampin
Ages
adults
Registry
NCT01947777

Full record on ClinicalTrials.gov

From the registry

To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects

Primary outcomes

  • Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656
  • Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656
  • Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656
  • Plasma concentrations of IPI-145 and its metabolite, IPI-656

History

  1. Last registry update

  2. Study completion

  3. Primary completion

  4. Started

  5. Registered