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

September 1, 2010 updated by: Oxagen Ltd

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Merthyr Tydfil, United Kingdom, CF48 4DR
        • Simbec Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OC000459
Drug: OC000459
OC000459 100mg tablet, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6.5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam
Time Frame: 6.5 days
6.5 days
Safety and tolerability of OC000459
Time Frame: 6.5 days
6.5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxagen Ltd

Investigators

  • Principal Investigator: Salvatore Febbraro, Dr, Simbec Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (ESTIMATE)

January 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2010

Last Update Submitted That Met QC Criteria

September 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • OC000459/014/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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