NCT01925911

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

A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) 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 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.

Detailed description

* 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IPI-145	25 mg BID Oral Capsule
DRUG	Midazolam	2 mg midazolam syrup

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2013-08-20
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States