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

Oxagen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: OC000459

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056575

OC000459/014/09

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

OC000459

Experimental group

Treatment:

Drug: OC000459