NCT01056575CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Oxagen Ltd
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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.
Arms & Interventions
OC000459
Experimental
Intervention: OC000459 (Drug)
Outcomes
Primary Outcomes
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
- Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam(6.5 days)
- Safety and tolerability of OC000459(6.5 days)
Investigators
Study Sites (1)
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