NCT02887443

A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate

An Open-label Study to Assess the Potential for Pre-systemic Inhibition of Cytochrome P450 3A4 (CYP3A) by Idebenone in Healthy Male Subjects Using Midazolam as a Substrate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers

Conditions

• Drug-Drug Interaction

Interventions

Type	Name	Description
DRUG	Raxone (idebenone 150 mg)	Raxone (idebenone 300 mg t.i.d.) on days 3 and days 5 to 10
DRUG	Midazolam 2,5 mg	Midazolam (2,5 mg single oral dose) on days 1, 3 and 10

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-09-02
• Last updated: 2017-10-05

Locations

1 site across 1 country: France