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

NCT02887443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-10-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887443 on ClinicalTrials.gov