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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oxagen Ltd
• Treatments: Indoleacetic Acids

Criteria

Inclusion Criteria:

• Judged to be in good health at screening (blood tests, physical examination, medical history)

Exclusion Criteria:

• Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.