NCT02118909

Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects

A Two-Part Study to Evaluate the Effect of CYP3A4 Inhibition (Itraconazole-Part 1) and CYP1A2 Inhibition (Ciprofloxacin - Part 2) on the Single-Dose Pharmacokinetics of Pracinostat in Healthy Nonsmoking Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.

Conditions

• Healthy Volunteers
• Non-smokers

Interventions

Type	Name	Description
DRUG	Pracinostat
DRUG	Itraconazole
DRUG	Ciprofloxacin

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2014-04-21
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States