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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: SAM-531 and gemfibrozil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SAM-531_gemfibrozil
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966966

Locations
Netherlands
Pfizer Investigational Site
Utrecht, Netherlands, 3584 CJ
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00966966     History of Changes
Other Study ID Numbers: 3193A1-1109, B1961001
Study First Received: August 26, 2009
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Alzheimer Disease

Additional relevant MeSH terms:
Gemfibrozil
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014