NCT01056575

Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4

An Open Label Balanced Study in Healthy Subjects to Evaluate the Potential for Cytochrome P 450 3A4 Induction by Oral OC000459 Using Oral Midazolam as a Probe

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oxagen Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days. Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	OC000459	OC000459 100mg tablet, twice daily

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2010-01-26
• Last updated: 2010-09-02

Locations

1 site across 1 country: United Kingdom