Overview

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

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Infinity Pharmaceuticals, Inc.
SecuraBio
Treatments:
Rifampin
Criteria
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