Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
An Open-label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-administered Orally to Healthy Young Adult Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of multiple doses of verapamil 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 verapamil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 alzheimer-disease
Started Oct 2008
Shorter than P25 for phase_1 alzheimer-disease
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
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFebruary 8, 2010
February 1, 2010
2 months
September 2, 2008
February 5, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
blood samples
7 weeks
Secondary Outcomes (1)
Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests
7 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
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
Study Sites (1)
Unknown Facility
Gières, 38610, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of 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
September 2, 2008
First Posted
September 3, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
February 8, 2010
Record last verified: 2010-02