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

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

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

• In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
• In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin

Inclusion Criteria:

• Healthy men or women of non-childbearing potential between 18-50 years of age
• Body Mass Index (BMI): 18.0 - 32.0 kg/m2
• In good health, determined by no clinically significant findings from clinical evaluations
• Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

• Women of childbearing potential
• Evidence of clinically significant medical conditions
• History of gastrointestinal disease or surgery that may affect drug absorption
• Positive or indeterminate Tuberculosis -spot test at screening
• Any active infection at the time of screening or admission
• Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge