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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Utrecht, , 3584 CJ Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00966966
Pfizer
Completed
Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

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Descriptive Information
Brief Title  ICMJE Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
SAM-531_gemfibrozil
Intervention: Drug: SAM-531 and gemfibrozil
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2010)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2009)
14
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion DateDecember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00966966
Other Study ID Numbers  ICMJE 3193A1-1109
B1961001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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