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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01947777

Run by

SecuraBio

People needed

14

Starts

2013-10-01

Expected to finish

2013-12-01

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRA International, Inc — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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