NCT01056575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 2, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

January 25, 2010

Last Update Submit

September 1, 2010

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

    6.5 days

Secondary Outcomes (2)

  • Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam

    6.5 days

  • Safety and tolerability of OC000459

    6.5 days

Study Arms (1)

OC000459

EXPERIMENTAL
Drug: OC000459

Interventions

OC000459DRUG

OC000459 100mg tablet, twice daily

OC000459

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Judged to be in good health at screening (blood tests, physical examination, medical history)

You may not qualify if:

  • Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Study Officials

  • Salvatore Febbraro, Dr

    Simbec Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

September 2, 2010

Record last verified: 2010-09

Locations

GB(1)