NCT00824057CompletedPhase 1
A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
Study Overview
Brief Summary
The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.
Exclusion Criteria
- •Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
- •Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
Arms & Interventions
1
Experimental
Intervention: AZD6280 (Drug)
1
Experimental
Intervention: Midazolam (Drug)
1
Experimental
Intervention: Caffeine (Drug)
Outcomes
Primary Outcomes
To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
Time Frame: Blood samples will be taken throughout the 19-day inpatient period of the study.
Secondary Outcomes
- To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.(Observations taken post dosing.)
- Evaluation of the pharmacodynamic effects of AZD6280(Test batteries will be performed before and following study drug administration.)
- To evaluate the pharmacokinetics of AZD6280(Blood samples will be taken throughout the 19-day inpatient period of the study.)
Investigators
Study Sites (1)
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