Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
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
2 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2009
CompletedFirst Posted
Study publicly available on registry
August 27, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 20, 2010
August 1, 2010
3 months
August 26, 2009
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum plasma concentration (Cmax)
24 days
Time to maximum plasma concentration (tmax)
24 days
Area under the concentration-time curve (AUC)
24 days
Secondary Outcomes (1)
Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests
24 days
Study Arms (1)
1
EXPERIMENTALSAM-531\_gemfibrozil
Interventions
2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizerlead
- Pfizercollaborator
Study Sites (1)
Pfizer Investigational Site
Utrecht, 3584 CJ, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 26, 2009
First Posted
August 27, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 20, 2010
Record last verified: 2010-08