Skip to main content
Clinical Trials/NCT01056575
NCT01056575CompletedPhase 1

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

Oxagen Ltd1 site in 1 country20 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Oxagen Ltd
Enrollment
20
Locations
1
Primary Endpoint
Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam.

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

OC000459

Experimental

Intervention: OC000459 (Drug)

Outcomes

Primary Outcomes

Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam.

Time Frame: 6.5 days

Secondary Outcomes

  • Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam(6.5 days)
  • Safety and tolerability of OC000459(6.5 days)

Investigators

Sponsor
Oxagen Ltd
Sponsor Class
Industry

Study Sites (1)

Loading locations...

Similar Trials