NCT00966966CompletedPhase 1
An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 country17 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration (Cmax)
Study Overview
Brief Summary
The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
- •Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.
Exclusion Criteria
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Arms & Interventions
1
Experimental
SAM-531_gemfibrozil
Intervention: SAM-531 and gemfibrozil (Drug)
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax)
Time Frame: 24 days
Time to maximum plasma concentration (tmax)
Time Frame: 24 days
Area under the concentration-time curve (AUC)
Time Frame: 24 days
Secondary Outcomes
- Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests(24 days)
Investigators
Study Sites (1)
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