NCT01947777

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IPI-145	25 mg oral capsule
DRUG	Rifampin	2x 300 mg oral capsule

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-09-20
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States