Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4
- Registration Number
- NCT01056575
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OC000459 OC000459 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam 6.5 days Safety and tolerability of OC000459 6.5 days
Trial Locations
- Locations (1)
Simbec Research Ltd
🇬🇧Merthyr Tydfil, United Kingdom