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Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00966966
First received: August 26, 2009
Last updated: August 18, 2010
Last verified: August 2010
History of Changes

August 26, 2009
August 18, 2010
September 2009
December 2009   (final data collection date for primary outcome measure)
  • Maximum plasma concentration (Cmax) [ Time Frame: 24 days ] [ Designated as safety issue: No ]
  • Time to maximum plasma concentration (tmax) [ Time Frame: 24 days ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve (AUC) [ Time Frame: 24 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00966966 on ClinicalTrials.gov Archive Site
Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: SAM-531 and gemfibrozil
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
Experimental: 1
SAM-531_gemfibrozil
Intervention: Drug: SAM-531 and gemfibrozil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00966966
3193A1-1109, B1961001
No
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP