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

Secura Bio

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Rifampin

Drug: IPI-145

Study type

Interventional

Funder types

Industry

Identifiers

NCT01947777

IPI-145-11

Details and patient eligibility

About

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

Full description

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

Enrollment

14 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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