NCT01549106

IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food and Ketoconazole on the Pharmacokinetics of IPI-145 When Administered to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	IPI-145	Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study
DRUG	Placebo	Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-03-08
• Last updated: 2021-03-17

Locations

1 site across 1 country: Netherlands