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Completed

NCT Number: NCT01056575

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Ltd

Merthyr Tydfil, CF48 4DR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OC000459

Drug

OC000459 100mg tablet, twice daily

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.

    Time frame: 6.5 days

Secondary outcomes

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

    Time frame: 6.5 days

  2. Safety and tolerability of OC000459

    Time frame: 6.5 days

Sponsors and collaborators

Lead sponsor

Oxagen Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 26, 2010
Registry last updated
Sep 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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