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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056575
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : September 2, 2010
Information provided by:
Oxagen Ltd

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: OC000459 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: OC000459 Drug: OC000459
OC000459 100mg tablet, twice daily

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056575

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United Kingdom
Simbec Research Ltd
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Oxagen Ltd
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Principal Investigator: Salvatore Febbraro, Dr Simbec Research
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Responsible Party: Dr C Mike Perkins, Oxagen Ltd Identifier: NCT01056575    
Other Study ID Numbers: OC000459/014/09
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2010