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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OC000459

Group Type EXPERIMENTAL

OC000459

Intervention Type DRUG

OC000459 100mg tablet, twice daily

Interventions

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OC000459

OC000459 100mg tablet, twice daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes