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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056575

Enrollment

Registered

2010-01-26

Start date

2010-02-28

Completion date

2010-05-31

Last updated

2010-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGOC000459

OC000459 100mg tablet, twice daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

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.	6.5 days

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026