Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4
This study has been completed.
Sponsor:
Oxagen Ltd
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01056575
First received: January 25, 2010
Last updated: September 1, 2010
Last verified: September 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 25, 2010 | ||||
| Last Updated Date | September 1, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01056575 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4 | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Healthy Volunteers | ||||
| Intervention ICMJE | Drug: OC000459
OC000459 100mg tablet, twice daily |
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| Study Arm (s) | Experimental: OC000459
Intervention: Drug: OC000459 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01056575 | ||||
| Other Study ID Numbers ICMJE | OC000459/014/09 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr C Mike Perkins, Oxagen Ltd | ||||
| Study Sponsor ICMJE | Oxagen Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oxagen Ltd | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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