drugset / Trial / NCT01056575

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

NCT01056575 ↗

Phase 1 Completed 20 enrolled Oxagen Ltd
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2010-02
Primary completion
2010-04
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject TIMAPIPRANT Small molecule 100 mg Oral

Indications

No indication recorded.