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

This study has been completed.
Sponsor:
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01056575
First received: January 25, 2010
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: OC000459
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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

Further study details as provided by Oxagen Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam [ Time Frame: 6.5 days ] [ Designated as safety issue: No ]
  • Safety and tolerability of OC000459 [ Time Frame: 6.5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OC000459 Drug: OC000459
OC000459 100mg tablet, twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056575

Locations
United Kingdom
Simbec Research Ltd
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Oxagen Ltd
Investigators
Principal Investigator: Salvatore Febbraro, Dr Simbec Research
  More Information

No publications provided

Responsible Party: Dr C Mike Perkins, Oxagen Ltd
ClinicalTrials.gov Identifier: NCT01056575     History of Changes
Other Study ID Numbers: OC000459/014/09
Study First Received: January 25, 2010
Last Updated: September 1, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 29, 2014