NCT01786382

A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole

A Phase 1, Open-Label Study to Evaluate the Potential Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole, and Potentially Telaprevir, in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Presidio Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of the study are to: * Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK) profile of midazolam following a single oral dose in human subjects. * Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject

Conditions

• Pharmacokinetic Assessments in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PPI-668
DRUG	Midazolam
DRUG	Omeprazole
DRUG	Telaprevir

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-02-08
• Last updated: 2013-03-26

Locations

1 site across 1 country: United States