NCT03209648

A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects

A Phase 1, Open-Label, Fixed Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Debio 1450	Debio 1450, 40 mg capsule.
DRUG	Itraconazole	Itraconazole, 20 mL of 10 mg/mL solution.

Timeline

• Start date: 2017-06-14
• Primary completion: 2017-08-23
• Completion: 2017-08-31
• First posted: 2017-07-06
• Last updated: 2017-10-18

Locations

1 site across 1 country: United Kingdom