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

NCT01056575 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-09-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

OC000459

OC000459 100mg tablet, twice daily

Sponsors & Collaborators

  • Oxagen Ltd

    lead INDUSTRY

Principal Investigators

  • Salvatore Febbraro, Dr · Simbec Research

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056575 on ClinicalTrials.gov