Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam (DDI)
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To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.
Condition or disease
Drug: IPI-145Drug: Midazolam
In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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